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Camrelizumab in Combination With PLD and Losartan in Patients With TNBC Who Have Received ≦ 1 Line of Chemotherapy

NCT05097248 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-10-28

No results posted yet for this study

Summary

This is a phase II, single-arm, multi-center, prospective clinical study of camrelizumab in combination with liposomal doxorubicin and losartan in patients with advanced or locally advanced triple-negative breast cancer who had received no more than 1 prior line of chemotherapy. Our aim was to explore the efficacy and safety of it.

Conditions

Interventions

DRUG

Camrelizumab

Camrelizumab 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every three weeks until unacceptable toxic effects or disease progression or other termination criteria appeared.

DRUG

Liposomal Doxorubicin

Liposomal Doxorubicin 40 mg/m2 on D1 every 3 weeks; 6 cycles are planned to be completed or discontinued due to intolerable toxicity or progression.

DRUG

Losartan

Losartan will be orally administered at 50 mg for three days and increased to 100 mg if tolerated until the whole course of chemotherapy; if not tolerated, it will be maintained at 50 mg until the whole course of chemotherapy

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    collaborator INDUSTRY

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Yanxia Zhao, M.D. · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2024-10-31
Completion
2024-10-31

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 NCT05097248 on ClinicalTrials.gov