Camrelizumab plus apatinib for high‑risk gestational trophoblastic neoplasia

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

This trial will test whether adding camrelizumab and apatinib to chemotherapy helps women with ultra high‑risk or chemo‑refractory/relapsed high‑risk gestational trophoblastic neoplasia achieve remission.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Female
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: bevacizumab, camrelizumab, chimeric antigen receptor, chemotherapy, immunotherapy, apatinib
• Locations: 1 site (Beijing)
• Trial ID: NCT05139095 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial enrolls women with ultra high‑risk GTN (Cohort A) and women with high‑risk chemo‑refractory or relapsed GTN (Cohort B) to receive camrelizumab plus the VEGFR2 inhibitor apatinib together with chemotherapy. Cohort A receives camrelizumab 200 mg IV every 2 weeks with apatinib 250 mg daily, consolidation chemotherapy after hCG normalization, then six months of maintenance camrelizumab plus apatinib; Cohort B receives camrelizumab 200 mg IV every 3 weeks with apatinib 250 mg daily plus chemotherapy. Treatment continues until completion, disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint is complete remission rate, with secondary endpoints including objective response rate, progression‑free survival, overall survival, duration of response, and safety.

Who should consider this trial

Good fit: Women aged 18–60 with ultra high‑risk GTN who are treatment‑naïve (Cohort A) or women with high‑risk GTN who have relapsed or are chemo‑refractory after two or more prior combination regimens (Cohort B), with ECOG 0–1 and measurable/abnormal hCG, are the intended participants.

Not a fit: Patients with poor performance status (ECOG >1), significant organ dysfunction, active autoimmune disease, or contraindications to immunotherapy or antiangiogenic therapy are unlikely to benefit from this regimen.

Why it matters

Potential benefit: If successful, this combination could raise complete remission rates and offer a new treatment option for women with ultra high‑risk or chemo‑refractory GTN.

How similar studies have performed: Combinations of PD‑1 inhibitors with antiangiogenic agents have shown promise in several solid tumors, but this specific camrelizumab plus apatinib approach in GTN is relatively novel with limited prior data.

Eligibility criteria

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 combination chemotherapies for high-risk chemo-refractory or relapsed GTN (Cohort B);
4. 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);
5. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
6. Patients with abnormal serum hCG level (≥5 IU/L);
7. Expected survival ≥ 4 months;
8. 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).
9. 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.
10. 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.

Exclusion Criteria:

1. 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;
2. Other malignancies in the past 3 years;
3. Immunosuppressive drugs used within 14 days prior to the first dose of camrelizumab; any active autoimmune disease or a history of autoimmune disease;
4. Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite with the optimal drug therapy);
5. 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;
6. 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;
7. 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;
8. With a history of psychotropic drug abuse and are unable to withdraw the psychotropic drug, or have mental disorders;
9. Major surgery performed within 4 weeks before the first dose of study drug, or open wounds or fractures;
10. 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;
11. Routine urine test indicating urinary protein ++ or more, or confirmed urinary protein ≥1·0 g within 24 hours;
12. 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;
13. Other reasons as judged by the investigator.

Where this trial is running

Beijing

• Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Yang Xiang

Conditions Gestational Trophoblastic Neoplasia