Sintilimab in Combination with Chemotherapy ± Local Treatment for Om-G/GEJ

NCT06739161 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: SCIR for G/GEJ
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric cancer is one of the most common and deadly cancers globally, with poor prognosis. About 70% of patients are diagnosed at an advanced stage, and the median overall survival (OS) is only 3-4 months. Current treatments, including immune checkpoint inhibitors combined with chemotherapy, have slightly improved survival, but most patients still experience disease progression during treatment, and those with PD-L1 CPS ≤5 do not benefit from immunotherapy. 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.

Conditions

Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival, defined as the time from randomization to disease progression or death, whichever occurs first.

  Progression will be assessed based on imaging studies and clinical evaluation, using RECIST v1.1 criteria. Data will be summarized using Kaplan-Meier estimates, and hazard ratios will be calculated.

  From the date of randomization until tumor progression or death from any cause, whichever occurs first, assessed up to 24 months

Secondary Outcomes (5)

• Overall Survival, defined as the time from randomization to death from any cause.

  From the date of randomization until death from any cause, assessed up to 36 months

• Objective Response Rate, defined as the proportion of participants achieving a complete or partial response, as assessed by RECIST v1.1 criteria.

  From the date of randomization until the date of first documented objective response, assessed up to 12 months

• Time to Progression, defined as the time from randomization to the first documented disease progression, as assessed by RECIST v1.1 criteria.

  From the date of randomization until the date of first documented progression, assessed up to 24 months

• Treatment Safety: Number of participants with treatment-related adverse events, as assessed by CTCAE v5.0.

  From the date of randomization until the end of treatment, assessed up to 18 months

• Time to Symptom Deterioration, based on patient-reported outcomes using validated quality of life instruments (e.g., EORTC QLQ-C30).

  From the date of randomization until the first documented symptom deterioration, assessed up to 12 months

Study Arms (2)

Sintilimab combined with chemotherapy and local treatment

EXPERIMENTAL

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.

Radiation: Sintilimab combined with chemotherapy and local treatment

Sintilimab combined with chemotherapy

ACTIVE COMPARATOR

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.

Combination Product: Sintilimab combined with chemotherapy only

Interventions

Sintilimab combined with chemotherapy and local treatment RADIATION

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 and local treatment

Sintilimab combined with chemotherapy only COMBINATION_PRODUCT

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.

Sintilimab combined with chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed esophagogastric junction (EGJ)/gastric adenocarcinoma.
• 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.
• No progression after two cycles of immunochemotherapy.
• Primary and metastatic lesions at diagnosis eligible for local treatment.
• All metastatic lesions measurable per RECIST 1.1.
• Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L.
• 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.
• Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min.
• Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN.
• No serious concomitant disease that will threaten the survival of patients to less than 5 years.
• Male or female. Age ≥ 18 years and ≤80 years.
• Written (signed) informed consent.
• Good compliance with the study procedures, including lab and auxiliary examination and treatment.
• Female patients should not be pregnant or breast feeding.

You may not qualify if:

• Non-adenocarcinoma histology of gastric/esophagogastric junction tumors, such as squamous cell carcinoma or neuroendocrine carcinoma.
• Esophagogastric junction/gastric adenocarcinoma with positive Her-2 status requiring anti-Her-2 treatment.
• Uncontrolled meningeal or peritoneal metastasis.
• Peripheral neuropathy of grade ≥2.
• Poor nutritional status, BMI \<18.5 kg/m², or PG-SGA score ≥9.
• Underwent major surgery or suffered a severe injury within 4 weeks prior to the first dose of the investigational drug.
• Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• Received any investigational drug within 4 weeks prior to the first dose of the study drug.
• 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.
• Received an anti-tumor vaccine or live vaccine within 4 weeks before the first dose of the study drug.
• Diagnosed with any active autoimmune disease or a history of autoimmune diseases.
• 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.
• Any condition within 14 days prior to treatment requiring systemic corticosteroid therapy (dose\>10mg/day of prednisone or equivalent) or other immunosuppressive treatments.
• Presence of uncontrolled cardiac symptoms or conditions, such as:
• NYHA Class II or higher heart failure

Sponsors & Collaborators

• Jiangsu Cancer Institute & Hospital: lead

Study Sites (1)

ChengChen

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Cheng Chen

  Jiangsu Cancer Institute & Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 18, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): December 2, 2027
• Study Completion (Estimated): December 2, 2028
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)