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A Prospective, Single-arm, Exploratory Clinical Study of Sintilimab Injection in Combination With Paclitaxel (Albumin-bound) and Gemcitabine in Translational Therapy in Patients With Unresectable Locally Advanced Pancreatic Cancer.

NCT05346146 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-04-26

No results posted yet for this study

Summary

Pancreatic cancer is a common malignant tumor of digestive tract, and its morbidity and mortality are increasing worldwide. Few clinical data have been published on immunotherapy for pancreatic cancer. This trial is a prospective, single-arm, single-center clinical study to investigate the efficacy and safety of sintilimab in combination with gemcitabine and albumin-paclitaxel conversion therapy with unresectable locally advanced pancreatic cancer.

Conditions

  • Unresectable Locally Advanced Pancreatic Cancer

Interventions

DRUG

Sintilimab; Gemcitabine; Albumin-paclitaxel

Sintilimab: 200mg IV Q3W D1; Gemcitabine: 1000mg/m2 IV Q3W D1,8; Albumin-paclitaxel：125mg/m2,IV,D1,D8,Q3W

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    collaborator INDUSTRY

  • RenJi Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2023-07-01
Completion
2024-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05346146 on ClinicalTrials.gov