Triple Therapy Sequential Radiotherapy in Unresectable HCC (TALENP003)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFujian Provincial Hospital
About this trial
This is an Open-label, Multicenter, Phase II clinical trial to evaluate the efficacy and safety of Transcatheter arterial chemoembolization (TACE), Lenvatinib combination with Sintilimab (Triple Therapy) sequential radiotherapy in patients with Unresectable Hepatocellular Carcinoma (uHCC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be willing and able to enrollment in this study, signing the informed consent form;
Age between 18 and 75 years old, male or female patients;
Child-Pugh class A;
Indocyanine green 15 min retention rate (ICGR-15) <15%;
Disqualifiers
Patients with a diagnosis of initial unresectable HCC, assessed as complete response (CR) or Progressive disease (PD) by RECIST 1.1 after 2 months of treatment with TACE, Lenvatinib combined with Sintilimab;
Tumor combined with cancerous thrombus in the inferior vena cava and the tumor has developed extrahepatic metastasis;
Treatment with other antitumor therapy such as targeted drugs, PD-1/PD-L1 inhibitors, surgery, TACE, radiotherapy, FOLFOX systemic chemotherapy, and locus coeruleus granule drugs prior to study entry;
History of allergy to Lenvatinib, Sintilimab and their components;
Trial population
Unresectable Hepatocellular Carcinoma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
TACE, Lenvatinib combination with Sintilimab sequential radiotherapy
Combination productTACE, Lenvatinib \[8mg(\<60kg)/12mg(\>60kg) orally daily\] combination with Sintilimab (200mg administered intravenous injection on Day 1 of each 21-day cycle) for 2 months. Sequential radiotherapy method and dosage are comprehensively evaluated by radiologists, hepatobiliary surgeons, and oncologists, and discussed by a multidisciplinary team
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: Triple Therapy sequential Radiotherapy1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate, ORR
The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate according to RECIST 1.1.
Time frame
4 weeks after the initiation of medication until the day before surgerySecondary outcomes
1
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 randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months2
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 randomization until the date of death from any cause, whichever came first, assessed up to 60 months3
Objective response rate, ORR
The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate according to mRECIST.
Time frame
4 weeks after the initiation of medication until the day before surgery4
Conversion resection rate, CRR
The Conversion resection rate (CRR) was defined as the patient who reach the resectable criterion after treatment and accepted operation.
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov