Combining PD-1 antibody with chemotherapy for advanced gastric cancer treatment

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

This study is testing whether combining a PD-1 antibody with a specific chemotherapy treatment can help people with advanced stomach cancer before and after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: chemotherapy, Nivolumab, immunotherapy
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT04908566 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of combining a PD-1 antibody with the FOLFIRINOX chemotherapy regimen in patients with locally advanced resectable gastric or gastroesophageal junction adenocarcinoma. The study aims to evaluate the safety and efficacy of this combination treatment in the perioperative setting. Eligible participants will receive either the PD-1 antibody with FOLFIRINOX or with the SOX regimen, based on their specific health conditions. The trial is designed to assess measurable tumor responses using established evaluation criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with untreated locally advanced resectable gastric or gastroesophageal junction adenocarcinoma.

Not a fit: Patients with distant metastasis, local invasion of adjacent organs, or tumor recurrence are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with locally advanced gastric cancer by enhancing the effectiveness of chemotherapy.

How similar studies have performed: Previous studies have shown promising results with similar combinations of PD-1 inhibitors and chemotherapy in treating gastric cancer.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. There are distant metastasis or local invasion of adjacent organs；
2. Tumor recurrence;
3. Suffered from or had previously suffered from autoimmune diseases;
4. Past organ transplantation or HIV patients;
5. Allergic to 5-fluorouracil, calcium leucoin, oxaliplatin, or irinotecan, or contraindications to 5-fluorouracil, calcium leucoin, oxaliplatin, or irinotecan exist;
6. Malignant secondary disease dating back to 5 years (exceptions: carcinoma in situ of the cervix, adequately treated basal cell carcinoma of the skin)；
7. Severe non-surgical complications or acute infections；
8. Peripheral polyneuropathy\>NCI Grad I；
9. 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)；
10. Subjects with symptomatic brain metastases;
11. Subjects with obvious clinical manifestations of arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, and severe valvular disease;
12. Subjects with severe bone marrow failure;
13. Psychotic subjects who are difficult to control；
14. Pregnant or lactating subjects;
15. Subjects whom the investigator considers inappropriate to participate in this trial；
16. Include in another clinical trial；

Where this trial is running

Tianjin, Tianjin Municipality

• RuiLiu — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Rui Lliu, Doctor of Oncology

Conditions Locally Advanced Gastric Adenocarcinoma