TACE Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGuohui Xu
About this trial
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most common cause of cancer-related death worldwide. The majority of patients with HCC are diagnosed as intermediate or advanced stage disease, and not eligible for curative treatments including transplantation, resection, and ablation. Transarterial chemoembolization (TACE) is recommended as first-line treatment for patients with intermediate-stage HCC, while it is also widely used in the unresectable HCC.
The clinical efficacy and safety in advanced HCC patients of camrelizumab plus apatinib were reported in phase 3 trial (CARES-310). Camrelizumab plus apatinib with a median progression-free survival of 5.7 months and a median overall survival of 22.1 months in advanced HCC.
This study is randomized, open-label, multicenter controlled trial; which was focused in initial BCLC-B/C HCC patients. This study aimed to compare the efficacy and safety of TACE plus programmed death-1 inhibitor (camrelizumab), and anti-angiogenic therapy (apatinib) with camrelizumab plus apatinib.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histopathologically or clinically confirmed hepatocellular carcinoma
18-80 years old.
Performance status (PS) ≤ 1 (ECOG scale).
Barcelona clinical liver cancer (BCLC) stage B or stage C.
Disqualifiers
Fibrolamellar carcinoma, sarcomatoid carcinoma, cholangiocarcinoma and other components previously confirmed by histology / cytology.
History of hepatic encephalopathy or liver transplantation.
Pleural effusion, ascites and pericardial effusion with clinical symptoms requiring drainage.
Tumor burden≥70%, diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation.
Trial design
Design model
Parallel
Treatments tested in this trial
TACE plus camrelizumab and apatinib
Combination productTACE plus camrelizumab and apatinib group: Patients who were randomized to this group, TACE is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery.Adriamycin(30 to 60 mg) and oxaliplatin (50-150mg) are considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion. The dose of lipiodol (5-20ml) and other embolic agent( blank microspheres/ PVA/gelatin sponge particles) were determined by diameter and blood supply type of HCC. Within 1 week after first TACE treatment, camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily.
Camrelizumab and apatinib
Combination productCamrelizumab and apatinib group: Patients who were randomized to this group, camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily.
Treatment groups
101 Participants
are divided into 2 treatment groupsGroup A: TACE plus camrelizumab and apatinibExperimental treatment 1 intervention
Group B: Camrelizumab plus apatinibActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
progression free survival (PFS)
Progression free survival period refers to the period from the beginning of treatment to the time when patients with cancer progress is observed or death occurs for any reason.
Time frame
Up to 24 months, from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 monthsSecondary outcomes
1
objective response rate (ORR)
The proportion of patients whose tumor volume reduction reaches the predetermined value and can maintain the minimum time limit. It is the sum of the proportion of complete response (CR) and partial response(PR). That is, ORR * CR + PR minimum time limit. It is the sum of the proportion of complete response (CR) and partial response(PR). That is, ORR * CR + PR
Time frame
within 1 year2
disease control rate (DCR)
It is the sum of the proportion of complete response (CR), partial response(PR) and stable disease(SD). That is, DCR = CR + PR + SD
Time frame
within 1 year3
overall survival (OS)
the time from the beginning of treatment to death caused by any reason (the last follow-up time is for the patients who lost the visit; the end of the study is for the patients who are still alive)
Time frame
From date of randomization until the date of study completion or date of death from any cause, whichever came first, assessed up to 48 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Guohui Xu
Lead sponsor
Sichuan Cancer Hospital and Research Institute
Sponsor institution
Source ClinicalTrials.gov