Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06472037

AG Combined With Cadonilimab Sequential Short-course Radiotherapy in the Treatment of Locally aPDAC

Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-12-04

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

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AI-Summary

What this Trial Is About

A prospective, single-arm, exploratory phase II clinical study evaluating the efficacy of Gemcitabine and Nab-palitaxe combined with Cadonilimab sequential short-course radiotherapy in the treatment of patients with locally advanced pancreatic ductal adenocarcinoma.

CONDITIONS

Official Title

AG Combined With Cadonilimab Sequential Short-course Radiotherapy in the Treatment of Locally aPDAC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent before any study procedures
  • Aged between 18 and 75 years
  • Diagnosed with pancreatic cancer confirmed by tissue examination
  • Locally advanced pancreatic ductal adenocarcinoma without prior anti-tumor treatment
  • Have at least one measurable tumor lesion on imaging
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Expected survival of more than 3 months
  • Adequate organ function meeting specific blood and liver test criteria
  • Negative pregnancy test for women of childbearing potential before treatment start
  • Use effective contraception during treatment and for 120 days after last study drug dose
Not Eligible

You will not qualify if you...

  • Having another malignant disease diagnosed within 5 years except certain skin cancers
  • Participating in another interventional clinical trial or using study drugs/devices within 4 weeks
  • Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or similar immune therapies
  • Systemic use of certain Chinese patent medicines or immunomodulatory drugs within 2 weeks before treatment
  • Active autoimmune disease needing systemic therapy within 2 years
  • Use of systemic glucocorticoids or immunosuppressants within 7 days before treatment start
  • History of organ or stem cell transplantation (except corneal)
  • Allergy to carfilzomib, gemcitabine, or albumin-bound paclitaxel ingredients
  • Not fully recovered from prior treatment toxicities above Grade 1 except fatigue or hair loss
  • Known HIV infection
  • Uncontrolled active hepatitis B or active hepatitis C infection
  • Recent live vaccine use within 30 days before treatment
  • Pregnant or breastfeeding women
  • Severe or uncontrolled systemic diseases including heart problems, unstable angina, recent arterial thrombosis, poorly controlled blood pressure, lung diseases, infections, liver disease, poorly controlled diabetes, significant proteinuria, or mental disorders
  • Any other condition that might interfere with study participation or results as determined by the investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China, 300052

Actively Recruiting

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Research Team

R

Rui Liu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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