Perioperative radiotherapy with SOX chemotherapy plus apatinib and camrelizumab for esophagogastric cancer

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

This trial tests whether adding apatinib and camrelizumab to SOX chemotherapy and radiotherapy before and after surgery helps adults with locally advanced gastric or GEJ adenocarcinoma.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Drugs / interventions: chemotherapy, camrelizumab, apatinib
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07026149 on ClinicalTrials.gov

What this trial studies

This Phase 2, single-center trial at Ruijin Hospital enrolls adults with previously untreated, localized (T3-4N+M0) gastric or gastroesophageal junction adenocarcinoma who are planned for surgery. Participants receive neoadjuvant radiotherapy combined with SOX chemotherapy plus apatinib (a VEGFR2 inhibitor) and camrelizumab (an anti–PD-1 antibody), followed by surgery and adjuvant courses of the same combination. The trial monitors safety, tolerability, and tumor response to see if the perioperative regimen increases rates of successful resection and reduces recurrence. Key eligibility includes ECOG 0–1 and adequate organ function, while patients with uncontrolled hypertension or bleeding disorders are excluded.

Who should consider this trial

Good fit: Adults with previously untreated, localized (T3-4N+M0) gastric or GEJ adenocarcinoma who are fit for surgery (ECOG 0–1), have adequate organ function, and agree to contraception if of childbearing potential are the intended participants.

Not a fit: Patients with uncontrolled hypertension, known bleeding or clotting disorders, known hypersensitivity to the study drugs, poor performance status, or metastatic disease are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could shrink tumors before surgery and reduce post‑surgical recurrence, potentially improving long‑term survival.

How similar studies have performed: Combining chemotherapy with anti–PD-1 agents and VEGFR inhibitors has shown promise in advanced gastric cancer, but using this combination perioperatively with concurrent radiotherapy is less well studied and remains exploratory.

Eligibility criteria

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)

Where this trial is running

Shanghai, Shanghai Municipality

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Shu-Bei Wang, MD

Conditions Gastric and Gastroesophageal Junction Adenocarcinoma