Neoadjuvant treatment for locally advanced gastric cancer using Sintilimab and chemotherapy

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 evaluates the efficacy and safety of a neoadjuvant regimen combining Sintilimab with weekly metronomic chemotherapy (PLOF) in patients with resectable locally advanced gastric cancer. The study will enroll 50 patients who will receive a specific chemotherapy regimen before undergoing radical surgery, followed by additional chemotherapy and immunotherapy postoperatively. The primary endpoints include the rates of pathological complete response (pCR) and major pathological response (MPR), with patients monitored for disease recurrence and overall survival for five years after surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed written Informed Consent Form
2. Male or female, age ≥ 18 years old
3. Histologically confirmed gastric adenocarcinoma, diagnosed as locally progressive according to the AJCC 8th ed, cTNM diagnosis of cT3-4aN1-3M0 and resectable lesion as assessed by the investigator
4. No prior systemic therapy such as surgery, radiotherapy, or immunotherapy for the disease at hand
5. Consent to radical surgical treatment and no contraindications to surgery as determined by the surgeon
6. ECOG PS: 0-1 score
7. Expected survival \> 6 months
8. Adequate organ function, must meet the following laboratory specifications:

   8.1 Absolute neutrophil count (ANC) ≥ 1.0x10\^9/L; 8.2 Platelets ≥ 80x10\^9/L; 8.3 Hemoglobin \> 7g/dL; 8.4 Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Total bilirubin \> 1.5 x ULN but direct bilirubin ≤ ULN are allowed to be enrolled); 8.5 AST, ALT ≤ 2.5×ULN; 8.6 Blood creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 ml/min; 8.7 INR or PT ≤ 1.5 times ULN; 8.8 TSH within normal range (Enrollment allowed if baseline TSH is outside normal range but FT4 is within normal range); 8.9 Myocardial enzyme profile within normal range;
9. Negative pregnancy test in women of childbearing age
10. Need to use contraception with an annual failure rate of less than 1% if there is a risk of conception

Exclusion Criteria:

1. Endoscopically show signs of active bleeding from the lesion
2. Current participation in an interventional clinical study or treatment with another investigational drug or use of an investigational device within 4 weeks prior to the first dose of study drug
3. Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or agents targeting CTLA-4, OX-40, CD137, etc.
4. Diagnosis of a malignant disease other than gastric cancer within 5 years prior to the first dose of therapy
5. Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose of the drug
6. Live vaccination within 30 days prior to the first administration of the drug
7. Have received systemic systemic therapy with proprietary Chinese medicines with antitumor indications or immunomodulatory drugs within 2 weeks prior to the first administration of the drug
8. Have received systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment
9. Has not fully recovered from any intervention-induced toxicity and/or complications (excluding malaise or alopecia) prior to initiation of therapy
10. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
11. Known hypersensitivity to drugs used in this study
12. Known history of HIV infection
13. Untreated active hepatitis B
14. Active HCV infection
15. Pregnant or lactating women
16. The presence of any serious or uncontrolled systemic disease
17. Other factors that, in the judgment of the investigator, may affect the outcome of the study

Where it's running

• Huashan Hospital, Fudan University
  Shanghai, China Recruiting

Similar studies

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

• Conversion therapy using disitamab vedotin (RC48), sintilimab, and SOX for HER2 IHC 1+ or 2+ unresectable gastric cancer

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• IBI343 plus sintilimab and chemotherapy for CLDN18.2-positive gastric or gastroesophageal junction cancer

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• Using immune checkpoint inhibitors to preserve organs in non-metastatic gastric or colon cancers

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• Sintilimab combined with chemoradiotherapy for elderly patients with advanced gastric cancer

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• Neoadjuvant therapy for HER2 positive locally advanced gastric cancer

  This study is testing a new treatment plan that combines radiation and medications to see if it can help people with advanced stomach cancer get ready for surgery.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT06487429

• Using Fecal Microbiota Transplantation with Chemotherapy and Immunotherapy for Advanced Gastric Cancer

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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.