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Can switching cancer therapy early extend life in stomach cancer?

NCT ID NCT07763171

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 244 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    42 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Italy

  • ASST Ospedale Maggiore di Crema

    Crema, Italy

  • ASST di Cremona

    Cremona, Italy

  • Azienda Ospedaliera Universitaria "Luigi Vanvitelli"

    Naples, Italy

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga

    Orbassano, Torino, Italy

  • Azienda Ospedaliera Universitaria di Modena

    Modena, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Italy

  • Azienda Ospedaliero-Universitaria Maggiore della Carità

    Novara, Italy

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, Italy

  • Azienda Sanitaria Territoriale di Pesaro e Urbino

    Pesaro, Italy

  • Azienda USL della Romagna

    Ravenna, Italy

  • Centro Riferimento Oncologico

    Aviano, Italy

  • Complexo Hospitalario Universitario de Ourense - CHUO

    Ourense, Spain

  • Fondazione Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, Italy

  • Fondazione I.R.C.C.S. Policlinico San Matteo

    Pavia, Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

    Milan, Italy

  • HUMV - Hospital Universitario Marqués de Valdecilla

    Santander, Spain

  • Hospital Clínico Universitario de Valencia

    Valencia, Spain

  • Hospital General Universitario Gregorio Marañón

    Madrid, Spain

  • Hospital Regional Universitario de Málaga

    Málaga, Spain

  • Hospital Universitario La Paz

    Madrid, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, Spain

  • Hospital Universitario de Navarra

    Pamplona, Spain

  • IRCCS Azienda ospedaliero-universitaria di Bologna - Policlinico Sant'Orsola

    Bologna, Italy

  • IRCCS Istituto Clinico Humanitas Research Hospital

    Rozzano, Milano, Italy

  • IRCCS Istituto Nazionale Tumori Regina Elena - RIN

    Roma, Italy

  • IRCCS Istituto Tumori Giovanni Paolo II

    Bari, Italy

  • IRCCS Ospedale Policlinico San Martino

    Genova, Italy

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples, Italy

  • Istituto Oncologico Veneto I.R.C.C.S

    Padova, Italy

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS

    Meldola, Italy

  • Krankenhaus Nordwest

    Frankfurt, Germany

  • Pia Fondazione PANICO

    Tricase, Lecce, Italy

  • Policlinico Tor Vergata

    Roma, Italy

  • Policlinico Universitario Fondazione Agostino Gemelli - Roma

    Roma, Italy

  • Prato Santo Stefano - Azienda Usl Toscana Centro

    Prato, Italy

  • Presidio Ospedaliero Ospedale del Mare

    Naples, Italy

  • Presidio Ospedaliero Universitario Santa Maria della Misericordia

    Udine, Italy

  • TUM Klinikum Rechts der Isar

    München, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Germany

  • Universitätsklinikum Ulm

    Ulm, Germany

  • Vall d'Hebron Barcelona Hospital

    Barcelona, Spain

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