Can switching cancer therapy early extend life in stomach cancer?
NCT ID NCT07763171
First seen Aug 13, 2026 · Last updated Aug 19, 2026 · Updated 3 times
Summary
This trial is testing whether switching to a different drug combination after initial chemotherapy can help people with advanced gastroesophageal cancer live longer without the disease worsening. Participants first receive standard chemotherapy plus an immunotherapy drug (tislelizumab). Those whose cancer does not progress are then randomly assigned to either continue the same chemotherapy plus tislelizumab or switch to a maintenance regimen of paclitaxel, ramucirumab, and tislelizumab. The goal is to see if the switch improves progression-free survival compared to continuing the original treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of paclitaxel, ramucirumab, and tislelizumab as switch maintenance therapy
- What this could lead to
- If successful, this approach could offer a new standard of care for advanced gastroesophageal cancer, potentially extending the time before the disease worsens and improving quality of life.
- What could go wrong
- This is a phase III trial, but results are not yet available. The switch maintenance may not improve outcomes compared to continuing chemotherapy, and the combination may cause more side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 244 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments. * Age ≥ 18 years on the day of signing the informed consent form. * Diagnosis of histologically confirmed gastroesophageal adenocarcinoma, either locally advanced unresectable or metastatic. * Locally assessed HER2-negative status and PD-L1 TAP score ≥5%. * No prior treatment for metastatic disease. Patients who received neoadjuvant, adjuvant or perioperative therapy and had disease recurrence beyond 6 months from the last dose are eligible. * Measurable and/or non-measurable evaluable disease according to RECIST v1.1. Note: The target lesion(s) selected have not been previously treated with local therapy OR The target lesion(s) selected that are within the field of prior local therapy have subsequently progressed as defined by RECIST v1.1. * ECOG Performance Status ≤ 1. * Life expectancy of at least 12 weeks in the opinion of the Investigator. * Adequate organ function as indicated by the following laboratory values during screening: a. Patients must not have required a blood transfusion or growth factor support ≤ 14 days before sample collection at screening for the following i. Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L ii. Platelets ≥ 100 x 10⁹/L iii. Hemoglobin ≥ 90 g/L b. Serum creatinine ≤ 1.5 x ULN (upper limit of normal) or estimated Glomerular Filtration Rate ≥ 60 mL/min/1.73 sqm. c. Serum total bilirubin ≤ 1.5 x ULN (total bilirubin must be \< 3 x ULN for patients with Gilberts syndrome). d. AST and/or ALT ≤ 2.5 x ULN, or ≤ 5 x ULN in case of liver metastases. e. Adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5, and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy). * The patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria ≥ 2+, then 24-hour urine must be collected and must demonstrate \< 1000 mg of protein in 24 hours to allow participation in the study. * Women of childbearing potential must have a negative blood pregnancy test at the baseline visit. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of amenorrhea, a single FSH measurement is insufficient. * Male subjects with female partners of childbearing potential and female subjects of childbearing potential must be willing to use adequate contraception as approved be the Investigator (barrier contraceptive measure or oral contraception), starting with the screening visit and ≥ 120 days after the last treatment dose of tislelizumab or ≥ 180 days after the last dose of chemotherapy or or ≥ 90 days after the last dose of ramucirumab. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. * Women must not be breastfeeding. * Archival tumor tissue (primary or metastatic) and blood samples are required for exploratory research at enrollment. Exclusion Criteria: * HER2-positive disease as determined by local standards. * Active leptomeningeal disease or uncontrolled brain metastases. Patients with treated, asymptomatic and radiologically stable brain metastases may be eligible according to protocol-defined criteria. * Active autoimmune disease or history of autoimmune disease that may relapse, except for protocol-specified conditions. * Any active malignancy within 3 years before enrollment, except for the cancer under investigation and protocol-specified malignancies treated with curative intent. * Any condition requiring systemic corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days before the first study treatment, except as specified in the protocol. * Uncontrolled diabetes; Grade \>1 abnormalities in potassium, sodium, or corrected calcium despite standard medical management; or Grade ≥3 hypoalbuminemia within 14 days before enrollment. * Child-Pugh B or worse cirrhosis, or cirrhosis of any degree with a history of hepatic encephalopathy or clinically meaningful ascites. * History of interstitial lung disease, non-infectious pneumonitis or uncontrolled pulmonary disease, severe dyspnea at rest, or requirement for supplemental oxygen. * Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy, including protocol-defined recent severe infections or antibiotic treatment. * Known active HIV infection, unless protocol-defined criteria for controlled HIV infection are met. * Acute or chronic hepatitis B, except for patients meeting protocol-defined criteria. * Acute or chronic hepatitis C, except for patients meeting protocol-defined criteria. * Any major surgical procedure requiring general anesthesia within 28 days before the first study treatment. * Prior allogeneic stem cell transplantation or organ transplantation. * Evidence of bleeding diathesis or coagulopathy. * Significant bleeding episodes from the gastrointestinal tract, gastrointestinal perforation and/or fistulae within 3 months before the first study treatment. * Serious or non-healing wound, peptic ulcer, or bone fracture within 3 months before the first study treatment. * Ongoing chronic therapy with NSAIDs or other antiplatelet agents. Aspirin at doses up to 325 mg/day is permitted. * Protocol-defined cardiovascular risk factors, including recent cardiac chest pain, Grade ≥3 venous thromboembolism, significant vascular disease, myocardial infarction, NYHA Class III-IV heart failure, Grade ≥2 ventricular arrhythmia, QTc \>470 msec, cerebrovascular accident, or uncontrolled hypertension. * Known hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. * Complete DPYD deficiency. Additional restrictions based on uracilemia apply at German sites. * Known allergy or hypersensitivity to any components used in the ramucirumab or tislelizumab preparations, or contraindications to protocol chemotherapy according to local prescribing information. * Receipt of chemotherapy, immunotherapy, or investigational therapy within 14 days or 5 half-lives, whichever is shorter, before the first study drug administration. * Extended-field radiation within 4 weeks or limited-field radiation within 2 weeks before the first study treatment. * Receipt of any herbal medicine used to control cancer within 14 days before the first study drug administration. * Administration of a live vaccine within 4 weeks before the first dose of study treatment. * Underlying medical conditions, laboratory abnormalities, or alcohol or drug abuse or dependence that could interfere with study treatment administration, interpretation of toxicity or adverse events, or compliance with study procedures. * Concurrent participation in another therapeutic clinical study. PRE-RANDOMIZATION CHECKLIST * Patients must continue to meet all applicable Induction phase inclusion and exclusion criteria before randomization. * Completion of the 12-week Induction phase therapy. * No permanent discontinuation of any study treatment administered during the Induction phase. * CR, PR, or SD as best response to Induction therapy for patients with measurable disease, or non-PD for patients with non-measurable disease, according to RECIST v1.1. * No contraindications to receiving ramucirumab before randomization, including: * No arterial thromboembolism or Grade ≥3 venous thromboembolism within the previous 3 months. * No full-dose anticoagulant therapy with warfarin, LMWH, or NOACs within the previous 3 months. Low-dose prophylactic anticoagulants are permitted. * No significant gastrointestinal bleeding, gastrointestinal perforation, and/or fistulae within the previous 3 months. * No major surgical procedure requiring general anesthesia within 28 days before the first study treatment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
42 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
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ASST Ospedale Maggiore di Crema
Crema, Italy
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ASST di Cremona
Cremona, Italy
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Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
Naples, Italy
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Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano, Torino, Italy
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Azienda Ospedaliera Universitaria di Modena
Modena, Italy
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Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
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Azienda Ospedaliero-Universitaria Maggiore della Carità
Novara, Italy
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Azienda Ospedaliero-Universitaria di Parma
Parma, Italy
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Azienda Sanitaria Territoriale di Pesaro e Urbino
Pesaro, Italy
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Azienda USL della Romagna
Ravenna, Italy
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Centro Riferimento Oncologico
Aviano, Italy
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Complexo Hospitalario Universitario de Ourense - CHUO
Ourense, Spain
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Fondazione Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy
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Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, Italy
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Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, Italy
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HUMV - Hospital Universitario Marqués de Valdecilla
Santander, Spain
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Hospital Clínico Universitario de Valencia
Valencia, Spain
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Hospital General Universitario Gregorio Marañón
Madrid, Spain
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Hospital Regional Universitario de Málaga
Málaga, Spain
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Hospital Universitario La Paz
Madrid, Spain
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Hospital Universitario Miguel Servet
Zaragoza, Spain
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Hospital Universitario de Navarra
Pamplona, Spain
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IRCCS Azienda ospedaliero-universitaria di Bologna - Policlinico Sant'Orsola
Bologna, Italy
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IRCCS Istituto Clinico Humanitas Research Hospital
Rozzano, Milano, Italy
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IRCCS Istituto Nazionale Tumori Regina Elena - RIN
Roma, Italy
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IRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy
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IRCCS Ospedale Policlinico San Martino
Genova, Italy
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Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Italy
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Istituto Oncologico Veneto I.R.C.C.S
Padova, Italy
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Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS
Meldola, Italy
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Krankenhaus Nordwest
Frankfurt, Germany
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Pia Fondazione PANICO
Tricase, Lecce, Italy
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Policlinico Tor Vergata
Roma, Italy
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Policlinico Universitario Fondazione Agostino Gemelli - Roma
Roma, Italy
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Prato Santo Stefano - Azienda Usl Toscana Centro
Prato, Italy
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Presidio Ospedaliero Ospedale del Mare
Naples, Italy
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Presidio Ospedaliero Universitario Santa Maria della Misericordia
Udine, Italy
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TUM Klinikum Rechts der Isar
München, Germany
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Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
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Universitätsklinikum Ulm
Ulm, Germany
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Vall d'Hebron Barcelona Hospital
Barcelona, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can Direct-to-Abdomen chemotherapy tame GI cancers that spread?
- Drug cocktail aims to shrink Hard-to-Treat stomach cancers
- New combo aims to keep stomach cancer at bay longer
- New cancer drug HH160 enters first human tests for advanced tumors
- Could a $4 statin improve cancer survival?
- Supercharged t cells take on Hard-to-Treat cancers