Conversion Therapy of Sintilimab in Combination With Fruquintinib and Chemotherapy Versus Sintilimab and Chemotherpay in Stage IV Gastric Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

June 30, 2024

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2027

Conditions
Gastric CancerGastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma
Interventions
DRUG

Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel

"Drug: Sintilimab Sintilimab 200mg, D1, IV, Q3W 4-8 cycles Drug: Fruquintinib Fruquinitinib 4mg/d, QD, PO, D1-D14, Q3W 4-8 cycles Drug: S-1 BSA\<1.25 m2, 40mg twice/day; BSA 1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, D1-D14, Q3W 4-8 cycles Drug: Nab-paclitaxel~* without peritoneal metastases: 260 mg/m2, IV, D1 for 3h, Q3W 4-8 cycles;~* with peritoneal metastases: 80mg/m2 IP, plus 180mg/m2, IV, D1, Q3W 4-8 cycles."

DRUG

Sintilimab + S-1 plus nab-paclitaxel

"Drug: Sintilimab Sintilimab 200mg, D1, IV, Q3W 4-8 cycles Drug: S-1 BSA\<1.25 m2, 40mg twice/day; BSA 1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, D1-D14, Q3W 4-8 cycles Drug: Nab-paclitaxel~* without peritoneal metastases: 260 mg/m2, IV, D1 for 3h, Q3W 4-8 cycles;~* with peritoneal metastases: 80mg/m2 IP, plus 180mg/m2, IV, D1, Q3W 4-8 cycles."

Trial Locations (1)

210000

Tianjin Medical University Cancer Institute and Hospital, Tianjin

All Listed Sponsors
lead

Tianjin Medical University Cancer Institute and Hospital

OTHER

NCT06454435 - Conversion Therapy of Sintilimab in Combination With Fruquintinib and Chemotherapy Versus Sintilimab and Chemotherpay in Stage IV Gastric Cancer | Biotech Hunter | Biotech Hunter