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
Qualifiers
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 design
Treatments tested in this trial
- TACE-HAIC, Envafolimab and Lenvatinib
Treatment groups
37 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov