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

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT05097248
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    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.
  • Liposomal Doxorubicin — DRUG
    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.
  • Losartan — DRUG
    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

Study Details

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.

Key Dates

Start date
Oct 31, 2021
Status verified
Oct 2021
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab, Liposomal doxorubicin and Losartan
    Participants receive intravenous camrelizumab (200 mg, Q3W) and liposomal doxorubicin (40 mg, Q3W for 6 weeks) plus oral losartan (50 mg loading dose followed by 100 mg QD, Q3W, until discontinuation of liposomal doxorubicin).

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Estimated 12 months ]

Central Contacts

Related Studies