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Trial Title:
Safety and Efficacy of Systemic Chemotherapy Plus PD-1 Inhibitor in Combination With Bevacizumab in Gastric Cancer With Peritoneal Metastasis
NCT ID:
NCT06487715
Condition:
Gastric Cancer Peritoneal Metastases
Conditions: Official terms:
Neoplasm Metastasis
Stomach Neoplasms
Paclitaxel
Bevacizumab
Albumin-Bound Paclitaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
albumin-bound paclitaxel (260 mg/m2, d1)
Description:
260 mg/m2, d1)
Arm group label:
Albumin-bound paclitaxel plus S1 and sintilimab in combination with Bevacizumab
Intervention type:
Drug
Intervention name:
S-1
Description:
80 mg/m2, d1-14
Arm group label:
Albumin-bound paclitaxel plus S1 and sintilimab in combination with Bevacizumab
Intervention type:
Drug
Intervention name:
sintilimab
Description:
200 mg, d1
Arm group label:
Albumin-bound paclitaxel plus S1 and sintilimab in combination with Bevacizumab
Intervention type:
Drug
Intervention name:
bevacizumab
Description:
First two cycles : intraperitoneally 7.5 mg/m2 Maintenance period: intravenously 7.5
mg/m2
Arm group label:
Albumin-bound paclitaxel plus S1 and sintilimab in combination with Bevacizumab
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.
Criteria for eligibility:
Criteria:
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 insufficiency, etc.) is not considered systemic therapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Start date:
March 1, 2024
Completion date:
March 1, 2026
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06487715
