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

Sponsor
Peking Union Medical College Hospital
Study ID
NCT05139095
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gestational Trophoblastic Neoplasia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab plus apatinib CohortA — DRUG
    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).
  • Camrelizumab plus apatinib Cohort B — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 27, 2022
Status verified
Apr 2025
Primary completion
Dec 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Population: ultra high-risk gestational trophoblastic neoplasia
  • Experimental: Cohort B
    Population: high-risk chemo-refractory or relapsed gestational trophoblastic neoplasia

Primary Outcome Measure

Cohort A: Complete remission rate [ Time Frame: up to one year ]

Central Contacts