Combining Sintilimab with Chemotherapy for Stage III Gastric Cancer Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical study aims to evaluate the efficacy and safety of Sintilimab combined with chemotherapy in patients with stage III gastric adenocarcinoma and esophagogastric junction adenocarcinoma following radical resection. Participants will receive either the SOX or XELOX chemotherapy regimen for a total of 16 cycles, with efficacy assessed every four cycles. The study includes comprehensive follow-up to monitor adverse events, disease status, and quality of life for up to five years post-treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18.
2. Patients with histopathological confirmed gastric/GEJ adenocarcinoma.
3. The pTNM is confirmed between IIIA-IIIC and the PD-L1 CPS\>=1.
4. Patients treated with D2 surgery.
5. ECOG is 0 or 1.
6. Patients who could tolerate chemotherapy combined with immunotherapy.
7. Patients who are not pregnant and have no willing to get pregnant within 6 months after the treatment is over.
8. Patients who are willing to offer their postoperative tumor tissue and their peripheral blood samples.
9. Patients who are volunteer to sign the ICF.

Exclusion Criteria:

1. Patients who had received neoadjuvent treatments before surgery.
2. Patients who have discovered tumor relapse or metastasis before adjuvent treatment.
3. Patients who have other malignant tumors.
4. Patients who could not swallow the tablets and capsules.
5. Other conditions which the researchers think are not suitable for participate the study.

Where it's running

• Cancer Hodpital, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: LIN YANG, Doctor — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: LIN YANG, Doctor
• Email: linyangcicams@126.com
• Phone: 010-13681015148

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• JS107 plus toripalimab and chemotherapy as first-line treatment for CLDN18.2-positive gastric cancer

  This trial tests whether JS107 added to toripalimab and XELOX is better than a similar regimen with sintilimab for patients with untreated, CLDN18.2-positive, HER2-negative advanced gastric or GEJ adenocarcinoma.

  Recruiting Phase 3 NingBo Junyan Hongshi Biosciences Co., Ltd · Guangzhou, Guangdong · NCT07584135

• Sintilimab added to SOX chemotherapy after surgery for PD-L1–positive pN3 gastric cancer

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  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07263386

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  Recruiting at 2 sites Phase 1 Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Frankfurt and 3 other locations · NCT07059299

• Neoadjuvant immunochemotherapy for advanced esophagogastric junction cancer

  This study is testing a new combination of immunotherapy and chemotherapy to see if it helps patients with advanced esophagogastric junction cancer before they have surgery.

  Recruiting Phase 2 Sun Yat-sen University · Guangzhou, Guangdong · NCT05170503

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  Recruiting Nanjing First Hospital, Nanjing Medical University · Nanjing, Jiangsu · NCT07914764

• Neoadjuvant immunotherapy plus Nab-P-SOX for locally advanced gastric/GEJ cancer

  This phase 2, single-arm study tests a pre-surgery treatment that combines a PD-1/CTLA-4 bispecific antibody with nab-paclitaxel, oxaliplatin, and S-1 in adults with HER2-negative, locally advanced gastric or GEJ cancer.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.