Sintilimab in Combination with Chemotherapy ± Local Treatment for Om-G/GEJ
NCT ID: NCT06739161
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2024-12-02
2028-12-02
Brief Summary
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Local radiotherapy, as a palliative treatment, can alleviate symptoms like bleeding, dysphagia, and pain, improving quality of life. Studies show that it significantly improves progression-free survival and may extend overall survival when added to chemotherapy. Therefore, combining local radiotherapy with immunochemotherapy may offer additional survival benefits for patients with advanced gastric cancer.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sintilimab combined with chemotherapy and local treatment
①Chemotherapy: Regimen follows guideline-recommended first-line therapy for advanced gastric cancer.
②Sintilimab (200 mg) is administered with chemotherapy every 21 days. Maintenance immunotherapy continues for up to 1 year after chemotherapy.
③Local Treatment : Performed during cycles 3-8 of immunochemotherapy. Radiotherapy is preferred, using a combination of high- and low-dose fractionation, tailored to tumor location, size, and proximity to critical organs.
Sintilimab combined with chemotherapy and local treatment
Treatment Regimens
①Chemotherapy: Regimen follows guideline-recommended first-line therapy for advanced gastric cancer.
②Sintilimab (200 mg) is administered with chemotherapy every 21 days. Maintenance immunotherapy continues for up to 1 year after chemotherapy.
③Local Treatment: Performed during cycles 3-8 of immunochemotherapy. Radiotherapy is preferred, using a combination of high- and low-dose fractionation, tailored to tumor location, size, and proximity to critical organs.
Alternative local treatments, such as radiofrequency ablation or surgery, may be used if suitable.
Sintilimab combined with chemotherapy
①Chemotherapy: Regimen follows guideline-recommended first-line therapy for advanced gastric cancer.
②Sintilimab (200 mg) is administered with chemotherapy every 21 days. Maintenance immunotherapy continues for up to 1 year after chemotherapy.
Sintilimab combined with chemotherapy only
Treatment Regimens ①Chemotherapy: Regimen follows guideline-recommended first-line therapy for advanced gastric cancer.
②Sintilimab (200 mg) is administered with chemotherapy every 21 days. Maintenance immunotherapy continues for up to 1 year after chemotherapy.
Interventions
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Sintilimab combined with chemotherapy and local treatment
Treatment Regimens
①Chemotherapy: Regimen follows guideline-recommended first-line therapy for advanced gastric cancer.
②Sintilimab (200 mg) is administered with chemotherapy every 21 days. Maintenance immunotherapy continues for up to 1 year after chemotherapy.
③Local Treatment: Performed during cycles 3-8 of immunochemotherapy. Radiotherapy is preferred, using a combination of high- and low-dose fractionation, tailored to tumor location, size, and proximity to critical organs.
Alternative local treatments, such as radiofrequency ablation or surgery, may be used if suitable.
Sintilimab combined with chemotherapy only
Treatment Regimens ①Chemotherapy: Regimen follows guideline-recommended first-line therapy for advanced gastric cancer.
②Sintilimab (200 mg) is administered with chemotherapy every 21 days. Maintenance immunotherapy continues for up to 1 year after chemotherapy.
Eligibility Criteria
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Inclusion Criteria
2. Oligometastatic disease diagnosed via CT, MRI, or PET/CT:≤3 extracranial organs involved, ≤5 total metastatic lesions, each ≤5 cm in diameter,Regional lymph nodes count as one station; distant nodes counted per station.
3. No progression after two cycles of immunochemotherapy.
4. Primary and metastatic lesions at diagnosis eligible for local treatment.
5. All metastatic lesions measurable per RECIST 1.1.
6. Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L.
7. 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.
8. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min.
9. Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN.
10. No serious concomitant disease that will threaten the survival of patients to less than 5 years.
11. Male or female. Age ≥ 18 years and ≤80 years.
12. Written (signed) informed consent.
13. Good compliance with the study procedures, including lab and auxiliary examination and treatment.
14. Female patients should not be pregnant or breast feeding.
Exclusion Criteria
2. Esophagogastric junction/gastric adenocarcinoma with positive Her-2 status requiring anti-Her-2 treatment.
3. Uncontrolled meningeal or peritoneal metastasis.
4. Peripheral neuropathy of grade ≥2.
5. Poor nutritional status, BMI \<18.5 kg/m², or PG-SGA score ≥9.
6. Underwent major surgery or suffered a severe injury within 4 weeks prior to the first dose of the investigational drug.
7. Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
8. Received any investigational drug within 4 weeks prior to the first dose of the study drug.
9. Required systemic treatment with corticosteroids (daily \>10 mg prednisone equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose of the investigational drug.
10. Received an anti-tumor vaccine or live vaccine within 4 weeks before the first dose of the study drug.
11. Diagnosed with any active autoimmune disease or a history of autoimmune diseases.
12. History of immunodeficiency, including a positive HIV test, any acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
13. Any condition within 14 days prior to treatment requiring systemic corticosteroid therapy (dose\>10mg/day of prednisone or equivalent) or other immunosuppressive treatments.
14. Presence of uncontrolled cardiac symptoms or conditions, such as:
* NYHA Class II or higher heart failure
* Unstable angina
* Myocardial infarction within the past year
* Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
15. Severe infection within 4 weeks prior to the first dose, including pneumonia requiring hospitalization, bacteremia, or infectious complications.
16. History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute pulmonary diseases.
17. Active pulmonary tuberculosis infection diagnosed by history or CT scan, or a history of active tuberculosis infection within the past year, or a history of untreated active tuberculosis infection more than one year ago.
18. Active hepatitis B or hepatitis C.
19. Laboratory abnormalities of sodium, potassium, or calcium greater than Grade 1 within 2 weeks before enrollment that cannot be corrected with treatment.
20. Known allergy to monoclonal antibodies, any PD-1 components, paclitaxel, capecitabine, or any components used in their formulations.
21. Pregnant or breastfeeding women, or women of childbearing potential who are unwilling or unable to use effective contraception.
18 Years
80 Years
ALL
No
Sponsors
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Jiangsu Cancer Institute & Hospital
OTHER
Responsible Party
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Cheng Chen
Principal Investigator
Principal Investigators
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Cheng Chen
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Cancer Institute & Hospital
Locations
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ChengChen
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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SCIR for G/GEJ
Identifier Type: -
Identifier Source: org_study_id