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A Randomized Trial of Surgical Decision-Making Guided by TDTP-RECIST

NCT07208526 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2025-10-06

No results posted yet for this study

Summary

This project aims to conduct a prospective, multicenter, randomized controlled clinical trial. The study plans to enroll 270 patients with locally advanced iCCA who have successfully undergone GOLP conversion therapy. Participants will be randomized at a 1:2:2 ratio into three arms: Control Arm (continued medication), Direct Surgery Arm, and TDTP-RECIST Assessment Arm. The primary endpoint is Overall Survival (OS).

Conditions

  • Intrahepatic Cholangiocarcinoma (Icc)
  • Conversion Therapy
  • TDTP-RECIST
  • GOLP Regimen

Interventions

DRUG

GOLP regimen

PD1 antibody (Toripalimab) combined with GEMOX chemotherapy and Lenvatinib neoadjuvant treatment

PROCEDURE

Surgery

R0 resection

DIAGNOSTIC_TEST

TDTP-RECIST

Treatment selection between continued GOLP therapy and surgical R0 resection based on TDTP-RECIST criteria.

Sponsors & Collaborators

  • Shanghai Geriatric Medical Center

    collaborator OTHER

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    collaborator OTHER

  • Shanghai 10th People's Hospital

    collaborator OTHER

  • Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University

    collaborator UNKNOWN

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Jia Fan, MD&PhD · Shanghai Zhongshan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2028-06-30
Completion
2028-12-31

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 NCT07208526 on ClinicalTrials.gov