NCT06359275

PD-1 Combined With Chemotherapy and PULSAR in LAPC and Local Recurrence Patients

A Phase II Study on the Safety and Efficacy of PD-1 Combined With Nab-paclitaxel/Gemcitabine and PULSAR in the Treatment of Locally Advanced Unresectable Pancreatic Cancer and Local Recurrence After Surgery.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery, to observe the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer.

Detailed description

This trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery, to observe the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS), surgical conversion rate, and quality of life were observed in subjects with locally advanced unresectable pancreatic cancer with precise histological or cytological diagnosis and patients with only local recurrence after surgery. This is a single-center study. A total of 46 subjects with locally advanced unresectable pancreatic cancer and 35 subjects with locally recurrent pancreatic cancer after surgery were planned to be enrolled. The estimated enrollment time is 18 months, with at least 18 months of follow-up for each subject. This trial will evaluate the safety data of all subjects who have received at least one dose of study treatment for analysis. The National Cancer Institute (NCI) Common Adverse Event Evaluation Criteria (CTCAE version 5.0) were used. The efficacy evaluation was done according to the clinical diagnosis and treatment routine-follow-up patients combined with follow-up records.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	PD-1	Toripalimab，240 mg/time，D1， Q3W
DRUG	Nab-paclitaxel	Nab-paclitaxel, 125mg/m2，IV，D1，8, Q3W
DRUG	Gemcitabine	Gemcitabine，1000mg/m2，IV，D1，8，Q3W
RADIATION	PULSAR	5-10 Gy per session, a total of 5 times.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-12-01
• Completion: 2027-10-01
• First posted: 2024-04-11
• Last updated: 2024-06-25

Locations

1 site across 1 country: China