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

  • STATUS
    Recruiting
  • End date
    Aug 9, 2028
  • participants needed
    124
  • sponsor
    Tianjin Medical University Cancer Institute and Hospital
Updated on 9 June 2021

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.

Details
Condition Locally Advanced Gastric Adenocarcinoma
Treatment PD-1 antibody combined with FOLFIRINOX regimen, PD-1 antibody combined with SOX program
Clinical Study IdentifierNCT04908566
SponsorTianjin Medical University Cancer Institute and Hospital
Last Modified on9 June 2021

Eligibility

Yes No Not Sure

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) <3.0109/L, neutrophils (ANC) <1.5109/L
platelets (PLT) <100109/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
valueCreatinine (Cr)>1.5 times the upper limit of the normal valueAlanine
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
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