Combination therapy for advanced gastric cancer

Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 Vs Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer: Randomized Control, Open, Multicenter Trial-2 (TAOS-3B-Trial-2)

This study is testing a new combination of treatments for advanced gastric cancer to see if it works better than the standard treatment for patients with larger tumors.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fujian Cancer Hospital (other gov)
• Drugs / interventions: immunotherapy, Tislelizumab, apatinib
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT05699655 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of Tislelizumab combined with apatinib, oxaliplatin, and S-1 compared to oxaliplatin and S-1 alone as neoadjuvant therapy for advanced gastric cancer. The study focuses on patients with large Borrmann III and IV types and bulky N positive tumors. Participants will undergo imaging to confirm measurable lesions and will be monitored for treatment response and safety throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with locally advanced gastric adenocarcinoma and measurable lesions.

Not a fit: Patients with prior surgical treatment or anti-tumor therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with advanced gastric cancer by enhancing tumor response before surgery.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy combinations in advanced gastric cancer, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Age: 18-70 years of age.
* Histologically confirmed gastric adenocarcinoma was diagnosed in patients with locally advanced gastric cancer with tumor volume \>5cm Borrmann III, Borrmann IV and BulkyN according to AJCC Version 8.
* Measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1.
* ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-1 scores.
* No previous surgical treatment, anti-tumor chemoradiotherapy/immunotherapy was performed.
* Preoperative endoscopic examination confirmed no positive peritoneal implantation metastasis and exfoliated cells.
* The expected survival time is more than 6 months.
* For women of reproductive age, a urine or serum pregnancy test with negative results should be performed within 3 days prior to receiving the first study drug administration (day 1 of cycle 1).If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested.Women of childbearing age were defined as at least 1 year after menopause or having undergone surgical sterilization or hysterectomy.

Exclusion Criteria:

* Diagnosis of malignant diseases other than gastric cancer within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resectable carcinoma in situ).
* Significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, etc. occurred within 3 months before enrollment. If fecal occult blood was positive at baseline, reexamination could be performed，if it was still positive after reexamination, gastroscopy was required.
* Prior treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137).
* A history of immunodeficiency, including HIV testing positive.
* Is currently participating in an interventional clinical study or has been treated with another study drug or study device in the 4 weeks prior to initial dosing.
* Patients who had a history of cardiovascular and cerebrovascular diseases and were still taking thrombolytic drugs or anticoagulants orally.
* HER2 positive is known.
* Patients with previous gastrointestinal perforation, abdominal abscess or recent intestinal obstruction (within 3 months) or imaging or clinical symptoms suggesting intestinal obstruction.

Where this trial is running

Fuzhou, Fujian

• Fujian cancer hospital — Fuzhou, Fujian, China (RECRUITING)

Study contacts

• Study coordinator: chen lu chuan, bachelor

Conditions: Immunotherapy Gastrict Cancer