Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Resectable Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: A Multicenter, Randomized Phase II-III Trial

NCT04208347 Phase 2/Phase 3 ACTIVE_NOT_RECRUITING

The study is being conducted to evaluate the efficacy, safety and tolerability of chemotherapy and apatinib with or without camrelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.

Details

Lead sponsor	Ruijin Hospital
Phase	Phase 2/Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	580
Start date	2019-12-18
Completion	2027-12

Conditions

• Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Interventions

• Apatinib 250mg
• Camrelizumab
• S-1, Oxaliplatin
• Apatinib 500mg

Primary outcomes

• Pathological Complete Response (pCR) — Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
• Event-free Survival (EFS) — Up to approximately 2 years

Countries

China