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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status and phase

Enrolling
Phase 2

Conditions

Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Treatments

Radiation: Preoperative Radiotherapy
Drug: Apatinib+Camrelizumab+SOX

Study type

Interventional

Funder types

Other

Identifiers

NCT07026149
2024373

Details and patient eligibility

About

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.

Enrollment

30 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

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Arm 1
Experimental group
Description:
Radiotherapy and Apatinib and Camrelizumab and S-1 and Oxaliplatin
Treatment:
Drug: Apatinib+Camrelizumab+SOX
Radiation: Preoperative Radiotherapy

Trial contacts and locations

1

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Central trial contact

Gang Cai, MD; Shu-Bei Wang, MD

Data sourced from clinicaltrials.gov

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