Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

cadonilimab(10mg/kg, iv,Q3W,D1) + regorafenib(80mg,PO,QD,everyday)

Cadonilimab+regorafenib

To evaluate the efficacy and safety of cadonilimab combined with regorafenib in patients with HCC who progressed on systemic therapy.

Currently, second-line treatment options for advanced HCC (aHCC) patients including single TKI or anti-PD-(L)1 remains limited survival benefits and objective responses. To explore more effective and safer second-line or later therapies for aHCC is necessary. Cadonilimab is a first-in-class humanized IgG1 bispecific antibody that binds to PD-1 and CTLA-4 simultaneously. Dual checkpoint inhibition of the PD-1 and CTAL4 pathways with single cadonilimab has the potential to boost immune surveillance in HCC. Previously data indicated that cadonilimab possesses an encouraging anti-tumour activity and an improved safety profile compared to the co-administration of anti-PD-1 plus anti-CTLA-4 antibodies. Regorafenib is a TKI and approved for second-line treatment of uHCC globally. Here, the investigators evaluated the safety of cadonilimab plus regorafenib as second-line or later therapy in patients with aHCC.

A Study of Cadonilimab Combined With Regorafenib in Patients With Advanced HCC

Cadonilimab Combined With Regorafenib for Patients With Hepatocellular Carcinoma Who Progressed on Systemic Therapy: An Open Label, Single Arm, Single Center, Prospective, Phase I/II Trial

Defined as proportion of patients who have CR, PR or SD according to RECIST v1.1

Defined as the time from enrollment to disease progression or death (whichever occurs first)

Defined as the time from enrollment to death from any cause

Defined as proportion of patients who have CR, PR or SD according to mRECIST

Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0

Spots Global Cancer Trial Database for cadonilimab+regorafenib