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Neo-adjuvant Chemo and Immunotherapy in the Pre-operAtive Treatment of Locally Advanced CholangIOcarciNoma

NCT06341764 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-11-07

No results posted yet for this study

Summary

Neoadjuvant chemo- and immunotherapy ameliorate the recurrence rate of cholangiocarcinoma (CCA) at 12 months after surgery.

Conditions

Interventions

DRUG

Durvalumab 1120 mg

Durvalumab 1120 mg day 1 i.v

DRUG

Durvalumab 1500 mg

Durvalumab i.v. at 1500 mg once every 4 weeks

DRUG

Tremelimumab i.v. at 300 mg

Single dose

COMBINATION_PRODUCT

Cisplatin (CDDP) 25 mg/mq i.v

Four cycles

COMBINATION_PRODUCT

Gemcitabine (GEM) 1000 mg/mq i.v.

Days 1 and 8 every 21 days

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Alessandro Ottaiano · IRCCS I.N.T. "G. Pascale"

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT06341764 on ClinicalTrials.gov