Sintilimab Combined With Fruquintinib and Chemotherapy Versus Sintilimab and Chemotherapy for Conversion Therapy in Unresectable Stage IV Gastric Cancer: a National Multicenter Randomized Controlled Study

Tianjin Medical University Cancer Institute and Hospital1 site in 1 country158 target enrollmentJune 2024

ConditionsGastric Cancer Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma

InterventionsSintilimab + Fruquinitinib + S-1 plus nab-paclitaxel Sintilimab + S-1 plus nab-paclitaxel

Overview

Phase: Phase 2
Intervention: Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel
Conditions: Gastric Cancer
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 158
Locations: 1
Primary Endpoint: R0-surgery conversion rate
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, open-label, phase 2 clinical study aiming to evaluate the feasibility and efficacy of sintilimab (PD-1 inhibitor) in combination of fruquintinib and chemotherapy (S-1 plus nab-paclitaxel) versus sintilimab and chemotherapy as conversion therapy in patients with stage IV gastric cancer in China.

Registry

clinicaltrials.gov

Start Date

June 2024

End Date

June 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed gastric/gastroesophageal junction adenocarcinoma through gastroscopy.
•Ages: 18-70 Years (concluding 18 and 70 Years)
•Life expectancy ≥3 months.
•Treatment-naive Stage IV (clinical staging, AJCC 8th) unresectable patients, no prior antitumor therapy (including radiation, chemotherapy, targeted therapy or immunotherapy, etc.).
•The Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0-
•Preoperative examinations using CT, MRI, PET-CT, etc., indicating only one unresectable factor OR peritoneal metastasis with another unresectable factor, such as:
•N3 lymph node metastasis, mainly referring to group 16 lymph node metastasis.
•Extensive or bulky lymph nodes (D2)
•Locally advanced T4b.
•Hepatic metastases (H1): ≤5 lesions with a total diameter ≤8cm.

Exclusion Criteria

•Has distal metastases other than oligometastases as defined in the inclusion criteria, such as pulmonary metastases, brain metastases, bone metastases, etc.
•HER-2 positive patients or willing to receive Trastuzumab.
•Endoscopic signs of active bleeding from the lesion.
•Patients with moderate/large volume of ascites.
•Near-obstruction at the cardia or pylorus affecting feeding and gastric emptying or difficulty swallowing tablets.
•Concurrently suffering from other serious illnesses that are difficult to control (Severe uncontrolled recurrent infections, atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction measurement under 50%, uncontrolled hypertension, renal insufficiency, symptomatic peripheral neuropathy, and NCI classification \>II)
•Has already on other medications prior to enrollment or could not be assured of compliance after enrollment.
•Allergy to any drugs in the regimen.
•Women who are pregnant or breastfeeding and have childbearing potential but are not taking adequate contraceptive measures.
•Organ transplant recipients requiring immunosuppression.