Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia

PHASE2RecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

January 27, 2022

Primary Completion Date

December 1, 2026

Study Completion Date

January 1, 2027

Conditions
Gestational Trophoblastic Neoplasia
Interventions
DRUG

Camrelizumab plus apatinib CohortA

Cohort A: Camrelizumab (200 mg q2w iv) concomitantly with apatinib (250 mg qd po) and EMA/CO \[etoposide, methotrexate, actinomycin D/cyclophosphamide, vincristine\] every 2 weeks. For certain patients with high tumor burden, 1-2 cycles of low-dose chemotherapy (actinomycin D 500 ug and etoposide 100mg/m2, D1-3) will be administered, then followed by EMA/CO. The observation period is 14 days.

DRUG

Camrelizumab plus apatinib Cohort B

Cohort B: Camrelizumab (200 mg q3w iv) concomitantly with apatinib (250 mg qd po) and multi-drug chemotherapy. The multi-drug chemotherapy regimen will be chosen by the investigator (chemotherapy regimen: EMA/CO \[etoposide, methotrexate, actinomycin D/cyclophosphamide, vincristine\]; or EMA/EP \[etoposide, methotrexate and actinomycin-D/etoposide, cisplatin\]; or FAEV \[floxuridine, actinomycin-D, etoposide, vincristine\]). The observation period is 21 days.

Trial Locations (1)

Unknown

RECRUITING

Peking Union Medical College Hospital, Beijing

All Listed Sponsors
collaborator

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

lead

Peking Union Medical College Hospital

OTHER