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

Anti-Infective Agents

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All Drugs and Chemicals

Cytarabine

Antimetabolites

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Immunologic Factors

The test is divided into 2 stages： fist stage is dose escalation：Sintilimab 200mg，MB07133 injection is divided into three dosage groups: 600mg/m2/day, 1200mg/m2/day, and 1800mg/m2/day.

second stage Dose expansion：Sintilimab 200mg+MB07133 1800mg/m2/day

1. Adopting the classic "3+3" scheme design, 3 dose groups, with a cycle of 21 days. On the first day of each cycle, a single infusion of Sintilimab is given, and MB07133 is given for 7 consecutive days after a 2-hour interval between infusion initiation.
2. Sintilimab 200mg+MB07133 1800mg, recruiting 30 subjects，the administration method is as 1.

Sintilimab 200mg+MB07133 600mg

Ding Yanhua

Ding Yanhua, master

An open-label, multi-dose clinical trial design was used to investigate the combination of MB07133 injection combined with Sintilimab in the treatment of primary liver cancer in phase I/IIa studies, including two phases of dose escalation and dose expansion，in order to evaluate the safety and efficacy of MB07133 injection combined with Sintilimab.

MB07133 600mg/m2/day+Sintilimab 200mg、 MB07133 1200mg/m2/day+Sintilimab 200mg、 MB07133 1800mg/m2/day+Sintilimab 200mg

Treatment of MB07133 Plus Sintilimab in Patients With Hepatocellular Carcinoma

Safety, Tolerability and Efficacy of MB07133 Plus Sintilimab in Patients With Hepatocellular Carcinoma，a Phase 1/2a Study

According to the internationally recognized NCI-CTCAE 5.0 toxicity evaluation standard

All adverse medical events that occur after subjects receive the investigational product can be manifested as symptoms, signs, diseases, or laboratory abnormalities, but do not necessarily have a causal relationship with the investigational product.

The time between the start of medication and the occurrence of objective tumor progression or death（RECIST1.1 ）

The First Hospital of Jilin University

Xi'an Xintong Pharmaceutical Research Co.,Ltd.

Spots Global Cancer Trial Database for sintilimab 200mg+mb07133 600mg