Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 80Years
All Genders
ID06095141

Cisplatin Based Regimen for Advanced Pancreatic Cancer Patients with Homologous Recombination Deficiency

Led by Fudan University · Updated on 2025-08-07

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to assess how well a cisplatin-based chemotherapy regimen works for patients with advanced pancreatic cancer who have homologous recombination deficiency (HRD). This subgroup of patients has specific genetic changes that may make them respond differently to treatments. The study focuses on those whose cancer has progressed after at least one prior chemotherapy and evaluates whether cisplatin can improve progression-free survival and other important outcomes. Participants will receive cisplatin at a dose of 25 mg/m2 through a 30-minute intravenous infusion on days 1 and 8 of each 21-day cycle. Other chemotherapy drugs may be given following standard guidelines depending on individual cases. Patients whose cancer is sensitive to platinum treatment may be offered a PARP inhibitor after six months of cisplatin therapy. Treatment cycles and response will be closely monitored throughout the study. During the trial, participants will be regularly assessed every four weeks for disease progression, tumor response, overall survival, and disease control using standard criteria. Researchers will conduct laboratory tests to ensure organ function and monitor safety. The study lasts until disease progression or other stopping criteria are met, with ongoing evaluations of treatment effects and participant well-being.

CONDITIONS

Brief Title

Cisplatin to Patients With Pancreatic Cancer and Homologous Recombination Deficiency

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and willing to sign informed consent
  • Age between 18 and 80 years
  • ECOG performance status of 0 to 2
  • Histologically or cytologically confirmed advanced pancreatic adenocarcinoma
  • Tumor progression after at least one line of chemotherapy
  • Genetic or molecular confirmation of homologous recombination deficiency
  • At least one measurable lesion according to RECIST criteria
  • Expected survival of at least 3 months
  • Adequate organ function based on laboratory tests
  • Agreement to use adequate contraception if of childbearing potential
Not Eligible

You will not qualify if you...

  • Pregnant or nursing women
  • Primary pancreatic cancer
  • Prior treatment with platinum drugs or PARP inhibitors
  • Diagnosis of non-adenocarcinoma pancreatic cancer by pathology
  • Inflammation of the digestive tract such as pancreatitis or cholecystitis
  • Severe or uncontrollable diseases affecting study compliance or results
  • Renal insufficiency or dialysis
  • Other serious illnesses that may endanger safety
  • Allergy to cisplatin or other platinum drugs
  • Unwillingness or inability to comply with study procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Repeated 21-day cycles until disease progression or discontinuation

Participants receive a cisplatin based chemotherapy regimen, administered intravenously on Days 1 and 8 of each 21-day cycle, to treat advanced pancreatic cancer with homologous recombination deficiency.

Visits every 21 days for treatment administration and assessments

Trial Site Locations

Total: 1 location

1

Shanghai Cancer Center

Shanghai, China

Actively Recruiting

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Research Team

Y

Ying Yang, MD

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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Published Research Related To This Trial

Randomized, Multicenter, Phase II Trial of Gemcitabine and Cisplatin With or Without Veliparib in Patients With Pancreas Adenocarcinoma and a Germline BRCA/PALB2 Mutation.

Eileen M O'Reilly, Jonathan W Lee, Mark Zalupski...

https://pubmed.ncbi.nlm.nih.gov/31976786