Triple threat before surgery: could a new combo wipe out stomach cancer cells?
NCT ID NCT05941481
First seen Jul 02, 2026 · Last updated Jul 02, 2026
Summary
This study tests whether giving a three-part treatment before surgery can improve outcomes for people with locally advanced stomach or gastroesophageal junction cancer. The treatment combines an immunotherapy drug (tislelizumab) with standard chemotherapy and a short course of radiation. The goal is to see if this approach can completely eliminate the tumor before surgery, potentially leading to better long-term results. The trial enrolls adults with specific stages of the disease who are healthy enough for surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tislelizumab (PD-1 antibody) combined with chemotherapy (capecitabine and oxaliplatin) and hypofractionated radiotherapy
- What this could lead to
- If successful, this approach could increase the chance of complete tumor removal during surgery and improve long-term survival for patients with locally advanced gastric cancer.
- What could go wrong
- This is a small Phase 2 trial, so results may not apply broadly. Combining treatments raises risks of side effects like immune reactions, fatigue, or digestive issues.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
21 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Jun 2026
- 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
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18 to 80 years
- Sex
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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 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: 1. Histologically or cytologically confirmed adenocarcinoma involving the gastroesophageal junction or gastric cardia. 2. Having an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 7 days before enrollment. 3. Being histologically diagnosed with adenocarcinoma. 4. Having tumor lesions at stomach or gastroesophageal junction (Siewert type II or III); 5. Clinically diagnosed stage T1-2N+M0/T3-T4aNanyM0 according to ultrasound endoscopy or enhanced CT/MRI scan. 6. At least one evaluable lesion in abdominal CT/MRI according to RESIST 1.1 is required. 7. Surgical consultation at enrolling site to confirm that patient will be able to undergo curative resection after completion of neoadjuvant therapy =\< 56 days prior to registration. 8. Physical condition and adequate organ function to ensure the success of abdominal surgery. 9. Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L. 10. Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \< 2.5 × ULN in the absence of liver metastases, or \< 5 × ULN in case of liver metastases. ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L. 11. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min. 12. Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN. 13. No serious concomitant disease that will threaten the survival of patients to less than 5 years. 14. Male or female. Age ≥ 18 years and ≤80 years. 15. Written (signed) informed consent. 16. Good compliance with the study procedures, including lab and auxiliary examination and treatment. 17. Female patients should not be pregnant or breast feeding. 18. Female patients of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Exclusion Criteria: 1. Patients with distant metastasis or unresectable primary lesion. 2. Received prior treatment or receiving current treatment for this malignancy. 3. Patients who have digestive tract bleeding in 2 weeks before recruitment or with high risk of bleeding. 4. Perforation / fistula of GI tract in 6 months before recruitment. 5. Patients with upper GI tract obstruction or functional abnormality or malabsorption syndrome, which can affect absorption of apecitabine. 6. Patients with active autoimmune disease or history of refractory autoimmune disease. 7. Patients with active malignant tumor in recent 2 years, except the tumor studied in this research or cured locally tumor like resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ. 8. Uncontrollable pleural effusion, pericardial effusion, or ascites in 2 weeks before recruitment. 9. Pulmonary disease history: interstitial pulmonary disease, non-infective pneumonitis, pulmonary fibrosis, acute pulmonary disease. 10. Uncontrollable systemic diseases, including diabetes, hypertension, etc. 11. Severe chronic or active infections in need of systemic antibacterial, antifungal, or antiviral treatment, including TB or HIV, etc. 12. Patients with untreated chronic hepatitis B or HBV DNA over 500 IU/ml or positive HCV RNA. 13. Patients with any cardiovascular risk factors below: 1. cardiac chest pain occurring in 28 days before recruitment, defined as moderate pain that limits daily activity. 2. pulmonary embolism with symptoms occurring in 28 days before recruitment. 3. acute myocardial infarction occurring in 6 months before recruitment. 4. any history of heart failure reaching grade 3/4 of NYHA in 6 months before recruitment. 5. ventricular arrhythmias of Grade 2 or grater in 6 months before recruitment, or accompanied by supraventricular tachyarrhythmias requiring medical treatment. 6. cerebrovascular accident within 6 months before recruitment. 14. Moderate or severe renal injury \[creatinine clearance rate≤50 ml/min (according to Cockroft \& Gault equation)\], or Scr\>ULN. 15. Dipyrimidine dehydrogenase (DPD) deficiency. 16. Allergic to any drug in this study. 17. History of allogeneic stem cell transplantation or organ transplantation. 18. Use of steroids (dosage\>10mg/d prednisone) or other systemic immune suppressive therapy in 14 days before recruitment, except patients treated with regimens below: a. steroids for hormone replacement (dosage\>10mg/d prednisone); b. steroids for local application with little systemic absorption; c. short -term (≤ 7 days) steroids for preventing allergy or vomiting. 19. Vaccinated with live vaccine in 4 weeks before recruitment. 20. Receiving immune (interleukin, interferon, thymin) treatment or treatment of other trials in 28 days before recruitment. 21. Receiving palliative radiation in 14 days before recruitment. 22. History of anti PD-1, PD-L1, PD-L2 or any other specific T cell co-stimulation or checkpoint pathway targeted treatment. 23. Patients who lose ≥20% of body weight within 2 months before enrollment. 24. For patients with uncontrolled epilepsy, CNS diseases or history of mental disorder, researchers should evaluate whether their diseases will impede their signing of informed consent or compliance of treatment. 25. Existing of potential situation which will impede drug administration or affect toxicity analysis or alcohol/ drug abuse.
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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.
Contacts and locations
Locations
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Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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