A Randomized Trial of Surgical Decision-Making Guided by TDTP-RECIST
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female aged 18-75 years;
Patients must provide signed informed consent prior to enrollment, demonstrating the ability to understand and willingness to sign the written informed consent form;
Pathologically confirmed diagnosis of intrahepatic cholangiocarcinoma;
Locally advanced disease, failure to achieve R0 resection, and absence of distant metastasis;
Disqualifiers
Pathologically diagnosed hepatocellular carcinoma, combined hepatocellular-cholangiocarcinoma, or other non-cholangiocarcinoma malignant components;
Patients with postoperative recurrence, or those who have previously received PD-1/PD-L1 antibodies, CTLA-4 antibodies, lenvatinib, or chemotherapy;
History or current diagnosis of other malignancies;
Active tuberculosis infection;
Trial design
Design model
Parallel
Treatments tested in this trial
GOLP regimen
DrugPD1 antibody (Toripalimab) combined with GEMOX chemotherapy and Lenvatinib neoadjuvant treatment
Surgery
Procedure/SurgeryR0 resection
TDTP-RECIST
Diagnostic testTreatment selection between continued GOLP therapy and surgical R0 resection based on TDTP-RECIST criteria.
Treatment groups
270 Participants
are divided into 3 treatment groupsGroup A: Medication GroupPlacebo comparator 1 intervention
Group B: Surgery GroupExperimental treatment 1 intervention
Group C: TDTP GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall survival
the time period from the randomization of the patient to the death event due to any reason
Time frame
24 monthsSecondary outcomes
1
Event-free survival
From randomization to the occurrence of the following events: disease progression prevents radical surgery; local or distant recurrence; second primary tumor; death due to various causes.
Time frame
24 months2
Objective response rate
The proportion of patients whose tumor volume has decreased to a predetermined value
Time frame
6 months3
Pathological remission rate
the ratio of the estimated active tumor size divided by the tumor bed size
Time frame
6 months4
Recurrence-free survival
the time from surgery to disease recurrence or all-cause death
Time frame
24 monthsOther outcomes
1
Exploratory markers
the relationship between treatment response and clinical factors: carcinoembryonic antigen (CEA), carbohydrate antigen 199 (CA199), carbohydrate antigen 125 (CA125), tumor mutation burden (TMB), PD-L1 expression, microsatellite instability (MSI), dynamic changes of PET-CT Standard uptake value, dynamic changes of contrast Ultrasound and MRI
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Zhongshan Hospital
Lead sponsor
Shanghai Geriatric Medical Center
Collaborator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Collaborator
Shanghai 10th People's Hospital
Collaborator
Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University
Collaborator
Source ClinicalTrials.gov
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