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

Phase 2

Recruiting

• Conditions: Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
• Interventions: Drug: Apatinib+Camrelizumab+SOX; Radiation: Preoperative Radiotherapy

• Registration Number: NCT07026149
• Lead Sponsor: Ruijin Hospital

Brief Summary

The study is being conducted to evaluate the efficacy, safety and tolerability of radiotherapy and chemotherapy, apatinib with camrelizumab in the neoadjuvant (prior to surgery) and adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-08
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-18
• Last Update Posted: 2025-06-18
• Primary Completion: 2025-09-01
• Study Completion: 2030-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Apatinib+Camrelizumab+SOX	Radiotherapy and Apatinib and Camrelizumab and S-1 and Oxaliplatin
Arm 1	Preoperative Radiotherapy	Radiotherapy and Apatinib and Camrelizumab and S-1 and Oxaliplatin

Primary Outcome Measures

Name	Time	Method
Pathological Complete Response	Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment

Secondary Outcome Measures

Name	Time	Method
Total Pathological Complete Response (tpCR)	Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
Major pathological response(MPR)	Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
Margin-free (R0) resection rate	Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
Lymph node status after neoadjuvant therapy (ypN staging)	Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
OS	up to 2 years
Local control rate	up to 2 years
AEs	Up to approximately 18 months
DFS	up to 2 years

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China