A Prospective, Open-label, Exploratory Basket Trial to Evaluate the Efficacy and Safety of Sintilimab Combined With Pyrotinib ± Chemotherapy in Patients With Advanced Digestive System Tumors

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

August 15, 2025

Primary Completion Date

December 31, 2030

Study Completion Date

April 1, 2031

Conditions
Advanced Digestive System Tumor
Interventions
DRUG

Sintilimab

Dosage Form: Intravenous (IV) infusion Dosage: 200 mg Frequency: Every 3 weeks (Q3W) Duration: Until disease progression, unacceptable toxicity, or up to 2 years

DRUG

Pyrotinib

Dosage Form: Oral tablet Dosage: 400 mg once daily (QD) Frequency: Continuous daily dosing Duration: Until disease progression or intolerable toxicity

DRUG

Optional Chemotherapy

"1. FOLFOX:~ Oxaliplatin 85 mg/m² IV Day 1, leucovorin 400 mg/m² IV Day 1, 5-FU 400 mg/m² IV bolus + 2400 mg/m² continuous infusion over 46h (Days 2-3)~2. GEMOX:~ Gemcitabine 1000 mg/m² and oxaliplatin 100 mg/m² IV Day 1~3. GC:~ Gemcitabine 1000 mg/m² and cisplatin 25 mg/m² IV on Days 1 and 8~4. XELOX (CapeOX) Oxaliplatin 130 mg/m² IV Day 1, capecitabine 1000 mg/m² PO BID Days 1-14~5. SOX:~ Oxaliplatin 130 mg/m² IV Day 1, S-1 PO BID Days 1-14 (dose based on BSA: \<1.25 m² = 40 mg, 1.25-\<1.5 m² = 50 mg, ≥1.5 m² = 60 mg)~6. TS:~ Paclitaxel 80 mg/m² IV Days 1 and 8, S-1 as above~7. mFOLFOX6: Same as FOLFOX; used primarily in colorectal cancer~8. FOLFIRINOX:~ Leucovorin 400 mg/m², 5-FU (bolus + continuous), irinotecan 180 mg/m², oxaliplatin 85 mg/m² IV Day 1~9. AG:~Nab-paclitaxel 125 mg/m² and gemcitabine 1000 mg/m² IV on Days 1 and 8"

Trial Locations (1)

430030

Tongji Hospital, Wuhan

All Listed Sponsors
collaborator

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

collaborator

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

lead

Tongji Hospital

OTHER

NCT07053150 - A Prospective, Open-label, Exploratory Basket Trial to Evaluate the Efficacy and Safety of Sintilimab Combined With Pyrotinib ± Chemotherapy in Patients With Advanced Digestive System Tumors | Biotech Hunter | Biotech Hunter