Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05139095
PHASE2

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

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of camrelizumab and apatinib as combination therapy in patients with ultra high-risk (Cohort A) and high-risk chemo-refractory or relapsed (Cohort B) gestational trophoblastic neoplasia (GTN). Eligible patients will receive camrelizumab plus apatinib plus chemotherapy. Treatment will be continued until disease progression, unacceptable toxicity, or withdrawal of consent.

Official title: Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia: a Cohort, Open-label, Phase 2 Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2022-01-27

Completion Date

2027-01-01

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

DRUG

Camrelizumab plus apatinib CohortA

Camrelizumab (200 mg q2w iv) concomitantly with apatinib (250 mg qd po) and EMA/CO (etoposide, methotrexate, actinomycin D/cyclophosphamide, vincristine, alternate weekly) chemotherapy. For patients with high tumor burden, 1-2 cycles of low-dose chemotherapy will be administered to avoid early death caused by sudden tumor collapse, then followed by standard chemotherapy of EMA/CO. The low-dose chemotherapy will be administered using AE (actinomycin D 500 ug and etoposide 100mg/m2, day 1-3,every 2 week) or EP (etoposide 100 mg/m2 and cisplatin 20 mg/m2, day 1-2, repeated weekly).

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.

Locations (1)

Peking Union Medical College Hospital

Beijing, China