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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• RuiLiu
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Rui Lliu, Doctor of Oncology
• Email: ec_tjcih@126.com
• Phone: 022-23341023

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 18F-FAPI PET/CT and laparoscopy for staging advanced stomach cancer

  This trial tests whether an 18F-FAPI PET/CT scan, used with laparoscopy, can better find spread of advanced stomach cancer and help doctors avoid unnecessary surgery.

  Recruiting Phase 2/3 Leiden University Medical Center · Almelo and 9 other locations · NCT07018661

• Comparing sequential S-1 therapy after surgery for advanced gastric cancer

  This study is testing if a specific treatment plan using S-1 therapy after surgery can help people with advanced stomach cancer recover better.

  Recruiting Phase 3 Zhejiang University · Hanzhou, Zhejiang · NCT05813015

• Personalized vaccine combined with pembrolizumab for advanced solid tumors

  This study is testing a new personalized cancer vaccine combined with pembrolizumab to see if it helps people with advanced solid tumors fight their cancer better.

  Recruiting Phase 1/2 Mayo Clinic · Jacksonville, Florida · NCT05269381

• Observing the safety of VYLOY in patients with gastric or GEJ cancer in South Korea

  This study is testing how safe the drug VYLOY is for people in South Korea with advanced stomach or gastroesophageal junction cancer who are receiving it as part of their regular treatment.

  Recruiting at 15 sites Astellas Pharma Inc · Goyang-si, Gyeonggi-do and 14 other locations · NCT06902545

• Zolbetuximab plus pembrolizumab and chemotherapy for stomach and gastroesophageal junction cancer

  This trial will test whether adding zolbetuximab to pembrolizumab and standard chemotherapy helps adults with Claudin 18.2-positive, HER2-negative locally advanced or metastatic stomach or gastroesophageal junction cancer.

  Recruiting at 187 sites Phase 3 Astellas Pharma Inc · Birmingham, Alabama and 252 other locations · NCT06901531

• Iparomlimab and Tuvonralimab (QL1706) plus SOX versus SOX alone for locally advanced gastric or gastroesophageal junction adenocarcinoma

  This trial will test whether adding the immunotherapy combination Iparomlimab and Tuvonralimab (QL1706) to standard SOX chemotherapy before and after surgery helps people with locally advanced gastric or gastroesophageal junction adenocarcinoma achieve complete tumor remission.

  Recruiting Phase 2 Shandong Provincial Hospital · Jinan, Shandong · NCT06829797

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.