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

NCT05139095 | Recruiting Phase 2

• 1 other identifier: MA-GTN-II-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Trophoblastic Neoplasia

Outcome Measures

Primary Outcomes (2)

• Cohort A: Complete remission rate

  The proportion of patients achieving complete remission. Complete remission is defined as normal serum β-hCG level measured for 3 consecutive weeks.

  up to one year

• Cohort B: Objective response rate

  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.

  up to one year

Secondary Outcomes (9)

• Cohort A: Objective response rate

  up to one year

• Cohort A: Progression-free survival

  up to one year

• Cohort A: Overall survival

  up to one year

• Cohort A: Duration of response

  up to one year

• Cohort A: Frequency and severity of adverse events

  up to one year

Study Arms (2)

Cohort A

EXPERIMENTAL

Population: ultra high-risk gestational trophoblastic neoplasia

Drug: Camrelizumab plus apatinib CohortA

Cohort B

EXPERIMENTAL

Population: high-risk chemo-refractory or relapsed gestational trophoblastic neoplasia

Drug: Camrelizumab plus apatinib Cohort B

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).

Also known as: Camrelizumab plus apatinib and multi-drug chemotherapy

Cohort A

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.

Also known as: Camrelizumab plus apatinib and multi-drug chemotherapy

Cohort B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Woman aged 18-60 years;
• Previously untreated patients with ultra high-risk GTN（Cohort A） or high-risk chemo-refractory or relapsed GTN (Cohort B);
• No previous chemotherapy or radiotherapy for ultra high-risk GTN（Cohort A）and have previously received two or more lines of combination chemotherapies for high-risk chemo-refractory or relapsed GTN (Cohort B);
• Patients with ultra high-risk GTN (FIGO stages I-III: score ≥13 and stage IV) according to the International Federation of Gynecology and Obstetrics (FIGO) 2000 staging and risk factor scoring system（Cohort A）and patients with a prognostic score ≥7 (Cohort B);
• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Patients with abnormal serum hCG level (≥5 IU/L);
• Expected survival ≥ 4 months;
• The function of vital organs meets the following requirements:
• hemoglobin ≥90 g/L, absolute neutrophil count ≥1·5×109/L, platelets ≥100×109/L; creatinine ≤1·5 × upper limit of normal (ULN), urea nitrogen ≤2·5×ULN; total bilirubin ≤ULN, alanine aminotransferase and aspartate aminotransferase ≤2·5×ULN, albumin ≥25 g/L; thyroid stimulating hormone ≤ULN (if thyroid stimulating hormone is abnormal, normal T3 and T4 can also be acceptable).
• Female patients of childbearing age must exclude pregnancy and are willing to use a medically approved high-efficiency contraceptive (e.g., intrauterine device, contraceptive or condom) during the study period and within 6 months of the last study drug administration.
• The patient should be aware of the purpose of the study and the operations required by the study and volunteer to participate in the study before sign the informed consent form.

You may not qualify if:

• Previous treatment with immunotherapy drugs (including antibodies targeting PD-1, PD-L1, cytotoxic T-lymphocyte-associated protein 4, T-cell receptor, chimeric antigen receptor T-cell therapy, and other immunotherapy), anti-angiogenic small-molecule tyrosine kinase inhibitors (such as pazopanib, sorafenib, or regorafenib), or anti-angiogenic monoclonal antibodies (such as bevacizumab); live vaccines injected within 4 weeks before the first dose of study drug; other clinical trials of antitumour drugs within 4 weeks before the first dose of study drug;
• Other malignancies in the past 3 years;
• Immunosuppressive drugs used within 14 days prior to the first dose of camrelizumab; any active autoimmune disease or a history of autoimmune disease;
• Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite with the optimal drug therapy);
• Grade II or higher myocardial ischemia, myocardial infarction or poorly controlled arrhythmia (females with QTc interval ≥470 ms); grade III to IV cardiac insufficiency according to New York Heart Association (NYHA) criteria, or cardiac color Doppler ultrasound evidence of left ventricular ejection fraction \<50%; myocardial infarction, NYHA grade II or above heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram suggesting acute ischemia or abnormal active conduction system occurring within 6 months before enrolment;
• Abnormal coagulation (international normalised ratio \>1·5×ULN or prothrombin time \>ULN+4 seconds or activated partial thromboplastin time \>1·5×ULN), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy;
• Severe infections within 4 weeks prior to the first dose of study drug (e.g., need of intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever (\>38·5°C) during screening or the first dose of study drug;
• With a history of psychotropic drug abuse and are unable to withdraw the psychotropic drug, or have mental disorders;
• Major surgery performed within 4 weeks before the first dose of study drug, or open wounds or fractures;
• Obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction, or sinus or perforation of empty organs within 6 months;
• Routine urine test indicating urinary protein ++ or more, or confirmed urinary protein ≥1·0 g within 24 hours;
• Human immunodeficiency virus infection or known acquired immunodeficiency syndrome, active hepatitis B (HBV DNA \>500 IU/mL), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of the analysis method) or co-infection with hepatitis B and hepatitis C;
• Other reasons as judged by the investigator.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Gestational Trophoblastic Disease

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Yang Xiang

CONTACT

010-69156068; XiangY@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2021
• First Posted: December 1, 2021
• Study Start: January 27, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)