Status:
RECRUITING
Immune Checkpoint Inhibitor PD-1 Antibody Combined With Chemotherapy in the Perioperative Treatment of Locally Advanced Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Locally Advanced Gastric Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 continu...
Eligibility Criteria
Inclusion
- 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
- 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；
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04908566
Start Date
May 1 2021
End Date
August 1 2028
Last Update
June 1 2021
Active Locations (1)
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1
RuiLiu
Tianjin, Tianjin Municipality, China, 300060