D-TACE-HAIC Combined With Envafolimab and Lenvatinib for Unresectable ICC
ConditionIntrahepatic Cholangiocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFujian Provincial Hospital
About this trial
This is a prospective, single-arm, multicenter, phase II trial to evaluate the efficacy and safety of D-TACE-HAIC (GEMOX protocol) in combination with Envafolimab and Lenvatinib for unresectable intrahepatic cholangiocarcinoma.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
1. Ages of 18 and 75;
2. Child-Pugh liver function grade: A/B;
3. ECOG score (see annex for scoring standards) : ≤1 score;
4. ICC was confirmed by pathology and evaluated by two senior hepatobiliary surgeons as unresectable for surgery (including multiple intrahepatic lesions, local vascular invasion, local lymph node metastasis, and distant metastasis);
Disqualifiers
1. Patients who have previously received other local anti-tumor treatments (such as radiotherapy, radiofrequency ablation, etc.), who are allowed to relapse 6 months after previous surgery, and who are allowed to undergo biliary drainage (including PTCD and biliary stent implantation);
2. History of allergy to gemcitabine, oxaliplatin, Envolizumab, Renvastinib and its components;
3. A history of other malignant tumors within the past 5 years or at the same time, except cured basal cell carcinoma of the skin, cervical carcinoma in situ and thyroid papillary carcinoma;
4. Patients who have previously received an organ transplant or are planning to receive an organ transplant;
Trial population
Patients diagnosed with unresectable intrahepatic cholangiocarcinoma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
TACE-HAIC, Envafolimab and Lenvatinib
DrugTACE-HAIC (GEMOX regimen) combined with Envafolimab and Lenvatinib
Treatment groups
37 Participants
are divided into 1 treatment groupGroup A: Combination therapy group1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate, ORR
The Objective response rate (ORR) was defined as the complete response (CR) rate or the partial response (PR) rate according to RECIST v1.1 criteria.
Time frame
Four weeks after the initiation of medicationSecondary outcomes
1
Overall survival, OS
The Overall survival (OS) was defined as the time between receiving treatment and observing death or loss of follow-up for any reason.
Time frame
From date of enrollment until the date of death from any cause, assessed up to 60 months2
Progression-free survival, PFS
The Progression free survival (PFS) was defined as the time between the start of treatment and the progression of intrahepatic and/or extrahepatic tumors, or the occurrence of death or loss of follow-up for any reason.
Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months3
Disease control rate, DCR
The Disease control rate (DCR) was defined as the complete response (CR) rate or the partial response (PR) rate or stable disease (SD) rate according to RECIST v1.1 criteria.
Time frame
Four weeks after the initiation of medication4
Treatment-related adverse events, TRAEs treatment-related adverse events
The incidence, spectrum and severity of adverse events (AE) and serious adverse events (SAE) were determined according to the NCI-CTCAE V5.0 standard. Dose suspension rate and dose termination rate due to adverse events.
Time frame
From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov