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

Regorafenib: 160 mg p.o. qd for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off).

Sintilimab: 200mg i.v. q3w.

Regorafenib + sintilimab

160 mg p.o. qd for 3 weeks of every 4 week cycle.

Regorafenib

Kangshun Zhu, Dr.

This study is conducted to evaluate the efficacy and safety of regorafenib plus sintilimab compared with regorafenib alone as the second-line treatment for patients with unresectable hepatocellullar carcinoma (HCC).

This is an open-label, multicenter, randomized controlled trial to evaluate the efficacy and safety of regorafenib plus sintilimab compared with regorafenib alone as the second-line treatment for unresectable HCC.

180 patients with unresectable HCC who progress after sorafenib or lenvatinib treatment or are intolerant to these drugs will be enrolled in the study. The Patients will be treated with regorafenib plus sintilimab or regorafenib alone using an 1:1 randomization scheme.

Regorafenib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. The administration of regorafenib will be delayed in cases of severe toxicities. And after recovery, regorafenib will be reintroduced at a reduced dose according to the dose delay and reduction guidelines. Treatment of sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. In the arm of regorafenib plus sintilimab, patients will be allowed to have regorafenib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

Regorafenib Plus Sintilimab vs. Regorafenib as the Second-line Treatment for HCC

Regorafenib Combined With Sintilimab Versus Regorafenib Alone as the Second-line Treatment for Unresectable Hepatocellular Carcinoma

The time from date of randomization until the first occurrence of disease progression or death due to any cause, whichever occurs first.

Number of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0.

The time from date of randomization to death due to any cause.

The time from date of randomization until the first occurrence of disease progression.

The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR).

The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD).

The percentage of patients who had a best overall tumor response rating of CR or PR.

The percentage of patients who had a tumor response rating of CR, PR, or SD.

Spots Global Cancer Trial Database for regorafenib + sintilimab