NCT06095141

Brief Summary

The purpose of this study is to evaluate the efficacy of cisplatin based regimen to patients with advanced pancreatic cancer and homologous recombination deficiency.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
6mo left

Started Dec 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Dec 2023Oct 2026

First Submitted

Initial submission to the registry

October 18, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Expected
Last Updated

August 7, 2025

Status Verified

December 1, 2024

Enrollment Period

1.9 years

First QC Date

October 18, 2023

Last Update Submit

August 4, 2025

Conditions

Pancreatic AdenocarcinomaHomologous Recombination Deficiency

Outcome Measures

Primary Outcomes (1)

  • progression-free survival, PFS

    PFS of subjects from recruiting to the time of disease progression

    At the end of Cycle 1 (each cycle is 21 days)

Secondary Outcomes (3)

  • objective response rate (ORR)

    At the end of Cycle 1 (each cycle is 21 days)

  • disease control rate (DCR)

    At the end of Cycle 1 (each cycle is 21 days)

  • Overall survival，OS

    At the end of Cycle 1 (each cycle is 21 days)

Study Arms (1)

Cisplatin

EXPERIMENTAL

Cisplatin 25 mg/m2, ivgtt, 30 min, D1, 8.

Drug: Cisplatin

Interventions

CisplatinDRUG

Cisplatin 25 mg/m2, ivgtt, 30 min, D1, 8. The administration of other chemotherapeutic agents including gemcitabine, nab-paclitaxel, fluorouracil, irinotecan, capecitabine is applied according to the National Comprehensive Cancer Network (NCCN) guideline. PARP inhibitor will be recommended to patients with platinum-sensitive metastatic PDAC after six months of cisplatin based regimen.

Cisplatin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to understand and the willingness to sign a written informed consent document.
  • Age ≥ 18 years and ≤ 80 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Histologically or cytologically confirmed advanced pancreas adenocarcinoma.
  • Tumor progression after at least one line of chemotherapy.
  • Genetic or molecular test confirmed the presence of homologous recombination deficiency.
  • Presence of at least of one measurable lesion in agreement to RECIST criteria.
  • The expected survival ≥ 3 months.
  • Adequate organ performance based on laboratory blood tests.
  • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

You may not qualify if:

  • Pregnant or nursing women.
  • Primary pancreatic cancer.
  • Patients who have received platinum or PARPi treatment.
  • The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
  • Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
  • Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
  • Renal insufficiency or dialysis
  • Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
  • Patients who are allergic to cisplatin or other platinum drugs.
  • Patients who are unwilling or unable to comply with study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Cancer Center

Shanghai, China

RECRUITING

Related Publications (2)

  • O'Reilly EM, Lee JW, Zalupski M, Capanu M, Park J, Golan T, Tahover E, Lowery MA, Chou JF, Sahai V, Brenner R, Kindler HL, Yu KH, Zervoudakis A, Vemuri S, Stadler ZK, Do RKG, Dhani N, Chen AP, Kelsen DP. Randomized, Multicenter, Phase II Trial of Gemcitabine and Cisplatin With or Without Veliparib in Patients With Pancreas Adenocarcinoma and a Germline BRCA/PALB2 Mutation. J Clin Oncol. 2020 May 1;38(13):1378-1388. doi: 10.1200/JCO.19.02931. Epub 2020 Jan 24.

    PMID: 31976786BACKGROUND

  • Golan T, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algul H, O'Reilly EM, McGuinness D, Cui KY, Schlienger K, Locker GY, Kindler HL. Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer. N Engl J Med. 2019 Jul 25;381(4):317-327. doi: 10.1056/NEJMoa1903387. Epub 2019 Jun 2.

    PMID: 31157963BACKGROUND

MeSH Terms

Interventions

Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Central Study Contacts

Ying Yang, MD

CONTACT

86 64175590yangying@fudanpci.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 23, 2023

Study Start

December 1, 2023

Primary Completion

October 31, 2025

Study Completion (Estimated)

October 31, 2026

Last Updated

August 7, 2025

Record last verified: 2024-12

Locations

CN(1)