NCT04324307

Study of Immunotherapy Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer

Multicenter, Open-label Clinical Study of PD-L1/CTLA4 BsAb Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of PD-L1/CTLA4 BsAb for the second line treatment and the combination with chemotherapy for the first line treatment in pancreatic cancer

Detailed description

Subjects who signed the informed consent were assigned to three cohorts according to the actual treatment status. Cohort 1 enrolled subjects receiving PD-L1/CTLA4 BsAb 5mg/kg iv Q2W for 2nd treatment; cohort 2 enrolled subjects receiving PD-L1/CTLA4 BsAb in combination with gemcitabine/albumin- paclitaxel as 1st treatment for 4-6 cycles with PD-L1/CTLA4 BsAb monotherapy maintainence; cohort 3 enrolled subjects received systemic chemotherapy, receiving PD-L1/CTLA4 BsAb combined with oxaliplatin / irinotecan / leucovorin / fluorouracil (FOLFIRINOX) as 1st treatment for 4-6 cycles withPD-L1/CTLA4 BsAb monotherapy maintainence; until disease progression according to RECIST 1.1, intolerable toxicity, withdrawal, death, 2-yr treatment,who comes first.

Conditions

• Locally Advanced and Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	PD-L1/CTLA4 BsAb	PD-L1/CTLA4 BsAb 5mg/kg, iv，Q2W
COMBINATION_PRODUCT	GP	Gemcitabine 1000mg/m2, iv, D1,8,15, 28days/cycle; nab-Paclitaxel 125mg/m2，iv，D1,8,15, 28days/cycle;
COMBINATION_PRODUCT	FOLFIRINOX	Fluorouracil 2400mg/m2，iv，D1, 14days/cycle; Oxaliplatin 68-85mg/m2，iv, D1,14days/cycle;Irinotecan135-180mg/m2，iv, D1, 14days/cycle;Calcium Folate 400mg/m2，iv, D1, 14days/cycle;

Timeline

• Start date: 2019-11-26
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2020-03-27
• Last updated: 2023-09-01

Locations

1 site across 1 country: China