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

Primary Purpose

Gastric Cancer

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

PD-1 inhibitor

Oxaliplatin

Capecitabine

Tegafur-gimeracil-oteracil potassium

5-FU

Radiotherapy

Chemotherapy

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PD-1 inhibitor and chemoradiotherapy

Chemotherapy

Arm Description

PD-1 inhibitor+CapeOX/SOX/FOLFOX for 6 weeks, followed by chemoradiotherapy; 6 weeks of PD-1 inhibitor and CapeOX/SOX/FOLFOX for 6 weeks after chemoradiotherapy, followed by PD-1 inhibitor, till 12 months after chemoradiotherapy. PD-1 inhibitor 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. Chemotherapy: CapeOx or SOX or FOLFOX therapy determined by investigator. Chemoradiotherapy Radiotherapy: 1.8 Gy/fx, 45-50.5Gy Chemotherapy: Capecitabine 625mg/m2 bid orally with radiotherapy; OR Tegafur-gimeracil-oteracil potassium combination drug 40-60mg bid orally with radiotherapy.

Chemotherapy: CapeOx or SOX or FOLFOX therapy determined by investigator. CapeOX: Oxaliplatin 130 mg/m2 (body surface area) solution intravenously once-daily, followed by 20 days off. Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off. SOX: Oxaliplatin 130 mg/m2 (body surface area) solution intravenously once-daily, followed by 20 days off. Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 14 days, followed by 7 days off. FOLFOX: Oxaliplatin 85 mg/m2 (body surface area) solution intravenously once-daily, followed by 13 days off. 5-FU 2400-2800mg/m2/d continuous intravenous pumping for 48h, Q2W.

Outcomes

Primary Outcome Measures

3-year DFS rate

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

Secondary Outcome Measures

3-year OS rate

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

3-year local recurrence free survival rate

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

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

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

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.

Full Information

NCT ID

NCT04997837

First Posted

July 21, 2021

Last Updated

August 1, 2021

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT04997837

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Recruiting

Study Start Date

July 21, 2021 (Actual)

Primary Completion Date

July 21, 2027 (Anticipated)

Study Completion Date

October 21, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

433 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PD-1 inhibitor and chemoradiotherapy

Arm Type

Experimental

Arm Description

Arm Title

Chemotherapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

PD-1 inhibitor

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Tegafur-gimeracil-oteracil potassium

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

5-FU

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Intervention Description

1.8 Gy/Fx, 45-50.4 Gy

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

3-year DFS rate

Description

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

Time Frame

Up to 3 years

Secondary Outcome Measure Information:

Title

3-year OS rate

Description

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

Time Frame

Up to 3 years

Title

3-year local recurrence free survival rate

Description

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

Time Frame

Up to 3 years

Title

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

Time Frame

Up to 28 days from last dose

Title

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

Description

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.

Time Frame

Through study completion, up to 10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhen Zhang, MD, PhD

Phone

18801735029

zhen_zhang@fudan.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhen Zhang, MD,PhD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhen Zhang, MD, PhD

Phone

18801735029

zhen_zhang@fudan.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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