Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04997837

Study of Adjuvant Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy in Resected pN3 Gastric (G) or GEJ Adenocarcinoma

The purpose of the study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with PD-1 inhibitors and chemoradiotherapy, in comparison with adjuvant chemotherapy only, in D2/R0 resected pN3 gastric or gastroesophageal junction adenocarcinoma. PD-1+CRT cohort: A total of 216 patients will receive 6 weeks of PD-1 inhibitors and chemotherapy, then receive concurrent chemoradiotherapy, followed by 6 weeks of PD-1 inhibitors and chemotherapy, finally receive maintenance treatment of PD-1 inhibitors until (maximum 1year after radiotherapy). CT cohort: A total of 217 patients will receive 6 months of chemotherapy. The disease-free survival(DFS), overall survival(OS) and adverse effects will be analyzed.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Zhen Zhang, MD, PhD

CONTACT

[email protected]

18801735029

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
  • Patients with expected survival time more than 6 months
  • Patients after standard D2/R0 resection
  • Postoperative histologically confirmed adenocarcinoma of the stomach or GEJ
  • Positive lymph nodes more than 7, stage pN3
  • Patients without distant metastasis (M0) or M1 with abdominal exfoliated cell detection positive (CY1P0)
  • Patients' physical condition and visceral function allows following adjuvant therapy, including chemotherapy, chemoradiotherapy and PD-1 inhibitor therapy.
  • Patients' blood routine and biochemical indicators should meet the following standard: Hb≥90g/L, ANC≥1.5*10^9/L, PLT≥100*10^9/L, ALT & AST≤2.5 U/L, TB ≤ 1.5 UNL, serum creatinine<1 UNL.
  • Patients who are willing to obey regimens during the study.
  • Written informed consent is acquired before random entry, and patients should know that he/she has the right to quit, and following treatment won't be affected.
  • Patients are willing to provide samples of blood and tissue.

Exclusion criteria

  • Patients with gross peritoneal metastasis (CY1P0 excluded) or distant metastasis.
  • Patients who has received any anti-tumor therapy before surgery.
  • Patients who had received radiotherapy for abdominal organs including stomach, liver, kidney, etc.
  • Patients who had active systematic autoimmune diseases which need systematic treatment within 2 years before first medication in the study, substitutive therapy (such as thyroxine, insulin, etc) excluded.
  • Patients diagnosed with immunodeficiency, or was receiving systematic glucocorticoid treatment or other immunosuppressive therapy within 7 days before medication, physiological dose of glucocorticoid is allowed (≤10 mg/d prednison or equivalent medication)
  • Patients who have known severe allergic reaction (≥level 3) to anti-PD-1 monoclonal antibody, 5-FU, Oxaliplatin or any auxiliary material.
  • Patient diagnosed with other malignant tumor in the past 5 years, excluding radical basal cell carcinoma of the skin and/or radical resected carcinoma in situ.
  • Patient with severe vital organ failure.
  • Pregnant or lactation period
  • Patient with known mental illness or drug abuse that may influence compliance.
  • Patient with known HIV infection, or active tuberculosis.
  • Untreated active hepatitis B
  • Patient with active HCV infection
  • Uncontrolled complications
  • Other situations that might disturb study results and compliance.

Treatment and study plan

PD-1 inhibitor

Drug

Nivolumab/Toripalimab 240mg solution intravenously once daily, Q2W. OR Nivolumab/Toripalimab 360mg solution intravenously once daily, Q3W; OR Pembrolizumab/Tilelizumab/Sintilimab/Carrelizumab, 200mg solution intravenously once daily, Q3W.

Oxaliplatin

Drug

CapeOx: 130 mg/m2 (body surface area) solution intravenously once-daily, followed by 20 days off.

FOLFOX: 85 mg/m2 (body surface area) solution intravenously once-daily, followed by 13 days off.

Capecitabine

Drug

CapeOx: 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.

Tegafur-Gimeracil-Oteracil Potassium

Drug

SOX: 40 - 60 mg bid orally in 14 days, followed by 7 days off

5-FU

Drug

FOLFOX:2400-2800mg/m2/d continuous intravenous pumping for 48h, Q2W

Radiotherapy

Radiation

1.8 Gy/Fx, 45-50.4 Gy

Chemotherapy

Drug

Capecitabine 625mg/m2 bid orally with radiotherapy; ORegafur-gimeracil-oteracil potassium combination drug 40-60mg bid orally with radiotherapy

Primary outcomes

  1. 3-year DFS rate

    Time frame: Up to 3 years

    Defined as the time from randomization to the date of first documented progression or death from any cause.

Secondary outcomes

  1. 3-year OS rate

    Time frame: Up to 3 years

    Defined as the time from randomization to death from any cause.

  2. 3-year local recurrence free survival rate

    Time frame: Up to 3 years

    Defined as the time from randomization to the date of first documented recurrence or death from any cause.

  3. Percentage of participants with treatment-related acute adverse events as assessed by CTCAE v5.0

    Time frame: Up to 28 days from last dose

  4. Quality of life as assessed by Quality of Life Scale (range 0-60)

    Time frame: Through study completion, up to 10 years

    It evaluates the quality of life from 12 aspects, including appetite, mental status, sleep quality, fatigue, etc. The higher scores mean a better quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhen Zhang, MD, PhD

CONTACT

[email protected]

18801735029

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Multicenter, Randomized, Controlled Phase III Study of Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy as Adjuvant Regimen for D2/R0 Resected pN3 Gastric (G) or Gastroesophageal Junction (GEJ) Adenocarcinoma

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Aug 10, 2021
Registry last updated
Aug 10, 2021

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.

Published trials that share one or more normalized conditions with this study.