NCT04191889: TRIPLET

A Trial of Hepatic Arterial Infusion Combined With Apatinib and Camrelizumab for C-staged Hepatocellular Carcinoma in BCLC Classification

Status unknown Phase 2 Last updated 13 September 2023

What this trial tests

Phase 2 trial testing Hepatic Arterial Infusion combined with Apatinib and Camrelizumab in C-staged Hepatocellular Carcinoma in BCLC Classification in 47 participants. Status unknown.

Timeline

13 April 2020

Primary endpoint
31 December 2023

31 December 2025

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	47
Start date	13 April 2020
Primary completion	31 December 2023
Estimated completion	31 December 2025
Sites	1 location across China

Drugs / interventions tested

• Hepatic Arterial Infusion combined with Apatinib and Camrelizumab

Conditions studied

• C-staged Hepatocellular Carcinoma in BCLC Classification — all drugs for C-staged Hepatocellular Carcinoma in BCLC Classification →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 70, any sex, with C-staged Hepatocellular Carcinoma in BCLC Classification. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study was designed to evaluate the effectiveness and safety of hepatic arterial infusion chemotherapy combined with Apatinib and Camrelizumab (Triplet-combined Therapy) for C-staged Hepatocellular Carcinoma in BCLC classification.

The primary outcome measure is to evaluate the objective response rate (ORR) of Triplet-combined Therapy for C-staged Hepatocellular Carcinoma in BCLC classification.

The secondary Outcome measures include the duration of response (DOR), disease control rate (DCR), progression-free survival rate (PFSR) \[ Time Frame: 6- and 12-month\], overall survival rate (OSR) \[ Time Frame: 6- and 12-month\], the median progression-free survival time (mPFS) and median overall survival time (mOS) of Triplet-combined Therapy for C-staged Hepatocellular Carcinoma in BCLC classification.

Moreover, this study aims to assess the safety and tolerability of Triplet-combined Therapy for C-staged Hepatocellular Carcinoma in BCLC classification.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Current Landscape of Immune Checkpoint Blockade in Hepatocellular Carcinoma: A Review.
   Pinter M, Jain RK, Duda DG. · · 2021 · cited 271× · PMID 33090190 · DOI 10.1001/jamaoncol.2020.3381
2. Hepatocellular Carcinoma Immune Landscape and the Potential of Immunotherapies.
   Giraud J, Chalopin D, Blanc JF, Saleh M. · · 2021 · cited 172× · PMID 33815418 · DOI 10.3389/fimmu.2021.655697
3. Inflammatory Mechanisms of HCC Development.
   Refolo MG, Messa C, Guerra V, Carr BI, et al · · 2020 · cited 149× · PMID 32164265 · DOI 10.3390/cancers12030641
4. Strategies to Improve the Antitumor Effect of Immunotherapy for Hepatocellular Carcinoma.
   Xing R, Gao J, Cui Q, Wang Q. · · 2021 · cited 136× · PMID 34899747 · DOI 10.3389/fimmu.2021.783236
5. Immunotherapy for Hepatocellular Carcinoma: Current Status and Future Prospects.
   Liu Z, Liu X, Liang J, Liu Y, et al · · 2021 · cited 109× · PMID 34675942 · DOI 10.3389/fimmu.2021.765101
6. Immune Checkpoint Inhibitors in the Treatment of HCC.
   Donisi C, Puzzoni M, Ziranu P, Lai E, et al · · 2020 · cited 105× · PMID 33585218 · DOI 10.3389/fonc.2020.601240
7. Normalization of the tumor microenvironment by harnessing vascular and immune modulation to achieve enhanced cancer therapy.
   Choi Y, Jung K. · · 2023 · cited 100× · PMID 37907742 · DOI 10.1038/s12276-023-01114-w
8. Camrelizumab (a PD-1 inhibitor) plus apatinib (an VEGFR-2 inhibitor) and hepatic artery infusion chemotherapy for hepatocellular carcinoma in Barcelona Clinic Liver Cancer stage C (TRIPLET): a phase II study.
   Zhang TQ, Geng ZJ, Zuo MX, Li JB, et al · · 2023 · cited 99× · PMID 37884523 · DOI 10.1038/s41392-023-01663-6