Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Resectable Gastric/Gastroesophageal Junction Adenocarcinoma

Treatments: Drug: Sintilimab; Drug: Sintilimab Placebo; Drug: Ipilimumab N01 Placebo; Drug: Oxaliplatin for injection; Drug: tegafur, Gimeracil and Oteracil Potassium Capsules; Drug: Ipilimumab N01

Study type: Interventional

Funder types: Industry

Identifiers

NCT07643623

CIBI310M301

Details and patient eligibility

About

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.

Enrollment: 720 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Signed written Informed Consent Form (ICF) and ability to comply with protocol-specified visits and related procedures.
2. Age ≥ 18 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
4. Expected survival ≥ 6 months.
5. 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.
6. 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.
7. 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

1. Histologically or cytologically confirmed other pathologic types (e.g., squamous cell carcinoma, sarcoma, undifferentiated carcinoma) or combined gastrointestinal stromal tumor (GIST) before randomization.
2. Suspicious metastatic lesions or locally advanced unresectable disease, regardless of stage.
3. 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.
4. Active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
5. Inability to swallow, malabsorption syndrome, or uncontrolled nausea/vomiting/diarrhea, or other severe gastrointestinal diseases affecting drug intake/absorption.
6. Any life-threatening bleeding event within 3 months before randomization, or grade 3/4 gastrointestinal/variceal bleeding requiring endoscopic/surgical intervention.
7. Active uncontrolled bleeding or known bleeding diathesis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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720 participants in 3 patient groups

Sintilimab

Active Comparator group

Description:

Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus chemotherapy in combination with Ipilimumab N01 prior to surgery. adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab plus chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.

Treatment:

Drug: tegafur, Gimeracil and Oteracil Potassium Capsules

Drug: Oxaliplatin for injection

Drug: Ipilimumab N01 Placebo

Drug: Sintilimab

Sintilimab+Ipilimumab N01

Experimental group

Description:

Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus chemotherapy in combination with Ipilimumab N01 prior to surgery. adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab plus chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.

Treatment:

Drug: Ipilimumab N01

Drug: tegafur, Gimeracil and Oteracil Potassium Capsules

Drug: Oxaliplatin for injection

Drug: Sintilimab

Sintilimab placebo+Ipilimumab N01 placebo

Active Comparator group

Description:

Neoadjuvant Treatment period: up to 3 cycles of sintilimab placebo plus chemotherapy in combination with Ipilimumab N01 Placebo prior to surgery. adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab placebo plus chemotherapy, and then receive sintilimab placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.

Treatment:

Drug: tegafur, Gimeracil and Oteracil Potassium Capsules

Drug: Oxaliplatin for injection

Drug: Ipilimumab N01 Placebo

Drug: Sintilimab Placebo