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TQB2450 Plus Anlotinib as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Resection

NCT05111366 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2022-05-04

No results posted yet for this study

Summary

This is An Open, Single Arm, Multicenter, Exploratory Phase II study, to evaluate the efficacy and safety of TQB2450 Plus anlotinib as adjuvant therapy in hepatocellular carcinoma(HCC) patients at high risk of recurrence after resection. The patients who are confirmed by Histology or cytology as HCC with high-risk recurrence after R0 liver resection will be enrolled. 18 cycles adjuvant treatment with TQB2450 Plus anlotinib can improve one-year recurrence free survival (RFS) rate of HCC patients after R0 surgical resection.

Conditions

Interventions

DRUG

TQB2450 injection

TQB2450 is an injection in the form of 1200mg, ivgtt, q3W.

DRUG

Anlotinib hydrochloride capsules

Anlotinib Hydrochloride is a capsule in the form of 8 mg,10 mg, and 12 mg, orally, once daily, 2 weeks on/1 week off.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    collaborator INDUSTRY

  • Xianhai Mao

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-06
Primary Completion
2024-01-20
Completion
2024-05-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05111366 on ClinicalTrials.gov