Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Oesophagogastric Cancer
- Conditions
- Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
- Interventions
- Registration Number
- NCT04208347
- Lead Sponsor
- Ruijin Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 580
- Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0;
- Plans to proceed to surgery following pre-operative chemotherapy.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Has adequate organ function.
- Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
- Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
- Has life expectancy of greater than 12 months.
- Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
- Known hypersensitivity to any of the study drugs or excipients.
- Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
- Congenital or acquired immune deficiency (e.g. HIV infected)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Apatinib and Camrelizumab and S-1 and Oxaliplatin Apatinib 250mg - S-1 and Oxaliplatin S-1, Oxaliplatin - Apatinib and Camrelizumab and S-1 and Oxaliplatin S-1, Oxaliplatin - Apatinib and S-1 and Oxaliplatin Apatinib 500mg - Apatinib and S-1 and Oxaliplatin S-1, Oxaliplatin - Apatinib and Camrelizumab and S-1 and Oxaliplatin Camrelizumab -
- Primary Outcome Measures
Name Time Method Event-free Survival (EFS) Up to approximately 2 years Pathological Complete Response (pCR) Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
- Secondary Outcome Measures
Name Time Method Margin-free (R0) resection rate Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment Major pathological response(MPR) Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment OS up to 3 years DFS up to 2 years AEs Up to approximately 18 months Downstaging of N stage Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Trial Locations
- Locations (23)
Affiliated Hospital of Hebei University
🇨🇳Baoding, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, China
Xiangya Hospital Central South University
🇨🇳Changsha, China
Heping Hospital Affiliated to Changzhi Medical College
🇨🇳Changzhi, China
Sichuan Cancer Hospital & Institute
🇨🇳Chengdu, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, China
The Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, China
Hainan Cancer Hospital
🇨🇳Haikou, China
Cancer Hospital of the University of Chinese Academy of Sciences
🇨🇳Hangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Scroll for more (13 remaining)Affiliated Hospital of Hebei University🇨🇳Baoding, China