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NOT YET RECRUITING
NCT06370754
PHASE1/PHASE2

Newly Emerging Immunotherapy for Pancreatic Cancer Treatment

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This is a Phase Ib/II platform clinical study to evaluate the initial efficacy and safety of different novel immunotherapies in patients with advanced pancreatic cancer.

Official title: A Phase Ib/II Platform Trial of Newly Emerging Immunotherapy for Pancreatic Cancer Treatment

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

117

Start Date

2024-04-30

Completion Date

2027-04-30

Last Updated

2024-04-17

Healthy Volunteers

No

Interventions

DRUG

JS001

240 mg by IV infusionevery 3 weeks (Q3W), given on cycle day 1.

DRUG

JS004

200 mg by IV infusion Q3W, given on cycle day 1.

DRUG

JS007

3mg/kg by IV infusion Q3W, given on cycle day 1.

DRUG

JS015

600mg by IV infusion Q3W, given on cycle day 1.

DRUG

Irinotecan Liposome Injection

60 or 70 mg/m\^2 by IV infusion every 2 weeks (Q2W), given on cycle day 1.

DRUG

5-Fluorouracil (5-FU)

2400mg/m\^2, intravenously, over 46 h on day 1, Q2W.

DRUG

Leucovorin (LV)

400mg/m\^2, intravenously, over 30 min on day 1, Q2W.

DRUG

Nab paclitaxel

125 mg/m\^2 by IV infusion Q3W, given on cycle day 1 and 8.

DRUG

Gemcitabine

1000 mg/m\^2 by IV infusion Q3W, given on cycle day 1 and 8.

Locations (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Shanghai, Shanghai Municipality, China