Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Oesophagogastric Cancer

Shanghai Jiao Tong University

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Treatments: Drug: Apatinib 500mg; Drug: Camrelizumab; Drug: S-1, Oxaliplatin; Drug: Apatinib 250mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04208347

DRAGON - IV

Ahead-G208 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 580 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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580 participants in 3 patient groups

Apatinib and Camrelizumab and S-1 and Oxaliplatin

Experimental group

Treatment:

Drug: Apatinib 250mg

Drug: S-1, Oxaliplatin

Drug: Camrelizumab

Apatinib and S-1 and Oxaliplatin

Experimental group

Treatment:

Drug: S-1, Oxaliplatin

Drug: Apatinib 500mg

S-1 and Oxaliplatin

Active Comparator group

Treatment:

Drug: S-1, Oxaliplatin