Not yet recruiting NCT07643623
Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tegafur, Gimeracil and Oteracil Potassium Capsules, Sintilimab Placebo, Sintilimab, Ipilimumab N01.
- Who it may be relevant to
- Registry conditions: Resectable Gastric/Gastroesophageal Junction Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
Overview
This is a Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined with Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma.
Interventions
- Drug tegafur, Gimeracil and Oteracil Potassium Capsules
40mg/m2, D1-14 BID PO Q3W - Drug Sintilimab Placebo
200 mg, D1 IV Q3W - Drug Sintilimab
200mg D1 IV Q3W - Drug Ipilimumab N01
1mg/kg, D1 IV Q6W - Drug Oxaliplatin for injection
130 mg/m2 D1 IV Q3W - Drug Ipilimumab N01 Placebo
1mg/kg, D1 IV Q6W
Primary outcome measures
- Major Pathological Response (MPR) rate in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma [Time frame: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )]
- Event-Free Survival (EFS) [Time frame: Up to approximately 5 years]
Secondary outcome measures (6)
- pathological Complete Response (pCR) rate [Time frame: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )]
- Clinical Down-staging Rate [Time frame: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )]
- R0 resection rate [Time frame: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )]
- Overall survival (OS) [Time frame: Up to approximately 5 years]
- numbers of subjects with adverse events [Time frame: Up to approximately 5 years]
- numbers of subjects with serious adverse events [Time frame: Up to approximately 5 years]
Eligibility criteria
Inclusion criteria
- Signed written Informed Consent Form (ICF) and ability to comply with protocol-specified visits and related procedures.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Expected survival ≥ 6 months.
- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ). For GEJ cancer, only Siewert type III and Siewert type II participants not requiring combined thoracotomy are eligible.
- Clinical stage T3-4Nany or TanyN+M0 (stage II-IVa) gastric/GEJ adenocarcinoma confirmed by endoscopic ultrasound or contrast-enhanced CT/MRI within 4 weeks before the first dose, per the American Joint Committee on Cancer (AJCC) 8th edition gastric cancer TNM staging system.
- Within 4 weeks before the first dose, evaluated by a responsible surgeon based on medical history and confirmed to meet study requirements for radical R0 resection.
Exclusion criteria
- Histologically or cytologically confirmed other pathologic types (e.g., squamous cell carcinoma, sarcoma, undifferentiated carcinoma) or combined gastrointestinal stromal tumor (GIST) before randomization.
- Suspicious metastatic lesions or locally advanced unresectable disease, regardless of stage.
- History of gastrointestinal perforation or fistula within 6 months before randomization. May be enrolled if perforation/fistula has been surgically treated (repaired/resected) and disease recovery/remission is confirmed by the investigator.
- Active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
- Inability to swallow, malabsorption syndrome, or uncontrolled nausea/vomiting/diarrhea, or other severe gastrointestinal diseases affecting drug intake/absorption.
- Any life-threatening bleeding event within 3 months before randomization, or grade 3/4 gastrointestinal/variceal bleeding requiring endoscopic/surgical intervention.
- Active uncontrolled bleeding or known bleeding diathesis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT07643623 · CIBI310M301