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OpenTrials
Active, Not Recruiting

NCT Number: NCT04208347

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma Adenocarcinoma Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Affiliated Hospital of Hebei University, Baoding, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Apatinib 250mg

Drug

Apatinib 250mg

Camrelizumab

Drug

Camrelizumab 200mg

S-1, Oxaliplatin

Drug

S-1, Oxaliplatin, q3w

Apatinib 500mg

Drug

Apatinib 500mg

Primary outcomes

  1. Pathological Complete Response (pCR)

    Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

  2. Event-free Survival (EFS)

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Major pathological response(MPR)

    Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

  2. Margin-free (R0) resection rate

    Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

  3. DFS

    Time frame: up to 2 years

  4. OS

    Time frame: up to 3 years

  5. Downstaging of N stage

    Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

  6. AEs

    Time frame: Up to approximately 18 months

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Dec 23, 2019
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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