Safety and Efficacy of Systemic Chemotherapy Plus PD-1 Inhibitor in Combination With Bevacizumab … (NCT06487715) | Clinical Trial Compass
UnknownPhase 2
Safety and Efficacy of Systemic Chemotherapy Plus PD-1 Inhibitor in Combination With Bevacizumab in Gastric Cancer With Peritoneal Metastasis
China42 participantsStarted 2024-03-01
Plain-language summary
It is an open label, phase II study involved receiving albumin-bound paclitaxel plus S-1 combined with sintilimab and bevacizumab in patients with gastric cancer peritoneal metastasis.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 to 75 years patients histologically or cytologically confirmed the presence of GC or gastroesophageal junction tumor with PM (HER2 negative). The ECOG performance status is 0-1 and the expected survival time is more than 3 months. Did not receive any therapy for GC within the last six months (chemotherapy, radiation therapy, or both).
Exclusion Criteria:
* Principal exclusion criteria: The obstruction of the cardia and pylorus affects the patient\'s eating and gastric emptying, or has difficulty swallowing tablets. HER2-positive GC and gastroesophageal junction tumors. Subject with other malignancies, except for non-melanoma skin cancer or in-situ cervical carcinoma under adequate treatment, or other treated malignancies without evidence of recurrence for 5 years. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or co-inhibit T cell receptors (eg, CTLA-4, OX-40, CD137). Received systemic treatment with Chinese medicines or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) with anti-tumor indications within 2 weeks before the first administration; Active autoimmune disease requiring systemic therapy (eg, disease-modifying drugs, glucocorticoids, or immunosuppressants) occurred within 2 years prior to first dose; Replacement therapy (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary…
What they're measuring
1
Overall survival rate
Timeframe: 1 year
Trial details
NCT IDNCT06487715
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology