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Immune Checkpoint Inhibitor PD-1 Antibody Combined With Chemotherapy in the Perioperative Treatment of Locally Advanced Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Primary Purpose

Locally Advanced Gastric Adenocarcinoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

PD-1 antibody combined with FOLFIRINOX regimen

PD-1 antibody combined with SOX program

About this trial

This is an interventional treatment trial for Locally Advanced Gastric Adenocarcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

At least 18 years of age, 75 years of age or less, no gender limitation;
Patients with untreated locally advanced resectable adenocarcinoma of the stomach or gastroesophageal junction, with clear pathological diagnosis;
According to RECIST 1.1, the efficacy evaluation standard for solid tumors, there were definite measurable and evaluable lesions, with spiral CT lesions ≥1cm；
Physical condition score KPS score 80-100 points ；
Able to receive systemic chemotherapy;
No obvious active bleeding;
No history of other malignancies, except cured carcinoma in situ of the cervix, basal carcinoma of the skin or squamous cell carcinoma;
Women of childbearing age had negative pregnancy test and had voluntarily taken effective and reliable contraceptive measures during the clinical trial；
Sign the informed consent form voluntarily；

Exclusion Criteria:

There are distant metastasis or local invasion of adjacent organs；
Tumor recurrence;
Suffered from or had previously suffered from autoimmune diseases;
Past organ transplantation or HIV patients;
Allergic to 5-fluorouracil, calcium leucoin, oxaliplatin, or irinotecan, or contraindications to 5-fluorouracil, calcium leucoin, oxaliplatin, or irinotecan exist;
Malignant secondary disease dating back to 5 years (exceptions: carcinoma in situ of the cervix, adequately treated basal cell carcinoma of the skin)；
Severe non-surgical complications or acute infections；
Peripheral polyneuropathy>NCI Grad I；
Impaired blood system, liver and kidney function. The evaluation criteria are as follows:
Blood routine: white blood cells (WBC) <3.0×109/L, neutrophils (ANC) <1.5×109/L, platelets (PLT) <100×109/L, hemoglobin (Hb) <90g/L.
Liver and kidney function: total bilirubin (TBIL)>1.5 times the upper limit of the normal value; urea nitrogen (BUN)>1.5 times the upper limit of the normal value；Creatinine (Cr)>1.5 times the upper limit of the normal value；Alanine aminotransferase and aspartate aminotransferase (ALT and AST)> 3 times the upper limit of the normal value (without liver metastasis)；Alanine aminotransferase and aspartate aminotransferase (ALT and AST)> 5 times the upper limit of the normal value (for liver metastases)；
Subjects with symptomatic brain metastases;
Subjects with obvious clinical manifestations of arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, and severe valvular disease;
Subjects with severe bone marrow failure;
Psychotic subjects who are difficult to control；
Pregnant or lactating subjects;
Subjects whom the investigator considers inappropriate to participate in this trial；
Include in another clinical trial；

Sites / Locations

RuiLiuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PD-1 antibody combined with FOLFIRINOX regimen

PD-1 antibody combined with SOX program

Arm Description

Outcomes

Primary Outcome Measures

Major pathological response(MPR)

Secondary Outcome Measures

Pathological complete response(pCR)

Disease-free survival(DFS) rate of 3 years

Time to relapse or progression of disease (PD) or death from any cause within 3 years from subject screening to first recorded

Disease-free survival(DFS) rate of 5 years

Time to relapse or progression of disease (PD) or death from any cause within 5 years from subject screening to first recorded

Full Information

NCT ID

NCT04908566

First Posted

April 27, 2021

Last Updated

May 27, 2021

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04908566

Brief Title

Immune Checkpoint Inhibitor PD-1 Antibody Combined With Chemotherapy in the Perioperative Treatment of Locally Advanced Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Official Title

Immune Checkpoint Inhibitor PD-1 Antibody Combined With Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX) Regimen vs. PD-1 Antibody Combined With Oxaliplatin, Tigio (SOX) Regimen During Perioperative Period A Randomized Controlled Phase II Clinical Study for the Treatment of Locally Advanced Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Recruiting

Study Start Date

May 2021 (Anticipated)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

August 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The FOLFIRINOX regimen has become the standard treatment regimen for advanced colorectal cancer, advanced pancreatic cancer and postoperative adjuvant treatment for pancreatic cancer. With the continuous exploration of Chinese scholars, it has also revised the modified dose suitable for the physical fitness of the Chinese people, which is well tolerated and has a clear efficiency. The drugs in this program are all standard treatment drugs for gastric cancer. In 2020, JAMA Network Open and JAMA Oncology successively reported the application of FOLFIRINOX in the perioperative period of gastric cancer and the late-stage results of gastric cancer, and they obtained very amazing data respectively. According to the results of CheckMate-649, the FDA approved Nivolumab combined chemotherapy for first-line treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, regardless of PD-L1 expression. At the same time, this is also the first first-line immunotherapy approved by the FDA for gastric cancer.However, there is no definite conclusion about the preoperative neoadjuvant or perioperative clinical research, so it is necessary to explore the efficacy of PD-1 antibody in the perioperative period. This study is a single-center, randomized, controlled phase II clinical study. The primary endpoint of the study is the perioperative administration of mFOLFIRINOX regimen combined with PD-1 antibody and D2 radical resection for the treatment of resectable advanced gastric cancer. The deep tumor remission rate (TRG0 and TRG1) , secondary endpoints include pCR rate, 3-year DFS rate, safety, R0 resection rate, D2 radical resection rate, 5-year DFS rate, 5-year OS rate.

6. Conditions and Keywords

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

Locally Advanced Gastric Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PD-1 antibody combined with FOLFIRINOX regimen

Arm Type

Experimental

Arm Title

PD-1 antibody combined with SOX program

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

PD-1 antibody combined with FOLFIRINOX regimen

Intervention Description

Give 240 mg of PD-1 antibody before each cycle of chemotherapy, d1; Chemotherapy regimen: irinotecan 150mg/m2, d1; fluorouracil 2400 mg/m², d1-2, continuous pumping for 46 hours; leucovorin 200 mg/m², d1; oxaliplatin 65 mg/m², d1; PD-1 antibody repeats once every 3 weeks; Chemotherapy is repeated every 2 weeks. 4 cycles before surgery. 4 cycles after operation。

Intervention Type

Drug

Intervention Name(s)

PD-1 antibody combined with SOX program

Intervention Description

Give 240 mg of PD-1 antibody before each cycle of chemotherapy, d1; Chemotherapy regimen: oxaliplatin 130 mg/m², d1, ticgio 40-60mg bid, d1-14 q3w;Repeat once every 3 weeks. 2-4 cycles before surgery. The perioperative period was 8 cycles.

Primary Outcome Measure Information:

Title

Major pathological response(MPR)

Time Frame

Surgery

Secondary Outcome Measure Information:

Title

Pathological complete response(pCR)

Time Frame

Surgery

Title

Disease-free survival(DFS) rate of 3 years

Description

Time to relapse or progression of disease (PD) or death from any cause within 3 years from subject screening to first recorded

Time Frame

progression of disease (PD) or death from any cause within 3 years

Title

Disease-free survival(DFS) rate of 5 years

Description

Time to relapse or progression of disease (PD) or death from any cause within 5 years from subject screening to first recorded

Time Frame

progression of disease (PD) or death from any cause within 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At least 18 years of age, 75 years of age or less, no gender limitation; Patients with untreated locally advanced resectable adenocarcinoma of the stomach or gastroesophageal junction, with clear pathological diagnosis; According to RECIST 1.1, the efficacy evaluation standard for solid tumors, there were definite measurable and evaluable lesions, with spiral CT lesions ≥1cm； Physical condition score KPS score 80-100 points ； Able to receive systemic chemotherapy; No obvious active bleeding; No history of other malignancies, except cured carcinoma in situ of the cervix, basal carcinoma of the skin or squamous cell carcinoma; Women of childbearing age had negative pregnancy test and had voluntarily taken effective and reliable contraceptive measures during the clinical trial； Sign the informed consent form voluntarily； Exclusion Criteria: There are distant metastasis or local invasion of adjacent organs； Tumor recurrence; Suffered from or had previously suffered from autoimmune diseases; Past organ transplantation or HIV patients; Allergic to 5-fluorouracil, calcium leucoin, oxaliplatin, or irinotecan, or contraindications to 5-fluorouracil, calcium leucoin, oxaliplatin, or irinotecan exist; Malignant secondary disease dating back to 5 years (exceptions: carcinoma in situ of the cervix, adequately treated basal cell carcinoma of the skin)； Severe non-surgical complications or acute infections； Peripheral polyneuropathy>NCI Grad I； Impaired blood system, liver and kidney function. The evaluation criteria are as follows: Blood routine: white blood cells (WBC) <3.0×109/L, neutrophils (ANC) <1.5×109/L, platelets (PLT) <100×109/L, hemoglobin (Hb) <90g/L. Liver and kidney function: total bilirubin (TBIL)>1.5 times the upper limit of the normal value; urea nitrogen (BUN)>1.5 times the upper limit of the normal value；Creatinine (Cr)>1.5 times the upper limit of the normal value；Alanine aminotransferase and aspartate aminotransferase (ALT and AST)> 3 times the upper limit of the normal value (without liver metastasis)；Alanine aminotransferase and aspartate aminotransferase (ALT and AST)> 5 times the upper limit of the normal value (for liver metastases)； Subjects with symptomatic brain metastases; Subjects with obvious clinical manifestations of arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, and severe valvular disease; Subjects with severe bone marrow failure; Psychotic subjects who are difficult to control； Pregnant or lactating subjects; Subjects whom the investigator considers inappropriate to participate in this trial； Include in another clinical trial；

Central Contact Person:

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

Rui Lliu, Doctor of Oncology

Phone

022-23341023

Ext

6012

ec_tjcih@126.com

Facility Information:

Facility Name

RuiLiu

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rui Liu

Phone

(022)23340123

Ext

6012

ec_tjcih@126.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

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Immune Checkpoint Inhibitor PD-1 Antibody Combined With Chemotherapy in the Perioperative Treatment of Locally Advanced Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

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