Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05139095 | Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia | PHASE2 | RECRUITING | 70 | — | — | Jan 27, 2022 | Jan 1, 2027 | Feb 5, 2026 | 1 | China |
The proportion of patients achieving complete remission. Complete remission is defined as normal serum β-hCG level measured for 3 consecutive weeks.
The proportion of patients with complete or partial response according to serum β-hCG level. Partial response is defined as a ≥50% decrease in β-hCG level from baseline after 2 cycles.
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | Population: ultra high-risk gestational trophoblastic neoplasia |
| Cohort B | EXPERIMENTAL | Population: high-risk chemo-refractory or relapsed gestational trophoblastic neoplasia |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: 1. Woman aged 18-60 years; 2. Previously untreated patients with ultra high-risk GTN（Cohort A） or high-risk chemo-refractory or relapsed GTN (Cohort B); 3. No previous chemotherapy or radiotherapy for ultra high-risk GTN（Cohort A）and have previously received two or more lines of...