Actively Recruiting
Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia: a Cohort, Open-label, Phase 2 Trial
Led by Peking Union Medical College Hospital · Updated on 2026-02-05
70
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination therapy using camrelizumab and apatinib in women with ultra high-risk and high-risk chemo-refractory or relapsed gestational trophoblastic neoplasia (GTN). This phase 2, open-label trial aims to study two groups: Cohort A with ultra high-risk GTN and Cohort B with high-risk GTN that has not responded to or has relapsed after chemotherapy. The study is sponsored by Peking Union Medical College Hospital and focuses on remission rates and response to treatment. In Cohort A, participants receive camrelizumab intravenously every two weeks, apatinib orally every day, and chemotherapy with specific drugs including etoposide, methotrexate, actinomycin D, cyclophosphamide, and vincristine. Treatment continues through normalization of serum beta-human chorionic gonadotropin levels, followed by four cycles of consolidation chemotherapy combined with camrelizumab and apatinib, then six months of maintenance with these drugs. In Cohort B, participants receive camrelizumab every three weeks, apatinib daily, and a chosen multi-drug chemotherapy regimen until disease progression or unacceptable side effects. Six cycles of consolidation therapy are given if a complete response is achieved. Participants will undergo regular assessments including blood tests to monitor hormone levels, organ function, and side effects. Researchers measure primary outcomes such as complete remission rate for Cohort A and objective response rate for Cohort B, alongside secondary outcomes like progression-free survival, overall survival, duration of response, and safety over up to one year. The total duration of participation depends on treatment response, side effects, or withdrawal of consent, with ongoing monitoring for disease progression and adverse events.
CONDITIONS
Brief Title
Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 60 years
- Diagnosed with ultra high-risk gestational trophoblastic neoplasia (Cohort A) or high-risk chemo-refractory or relapsed gestational trophoblastic neoplasia (Cohort B)
- No prior chemotherapy or radiotherapy for ultra high-risk GTN (Cohort A)
- Have received two or more lines of combination chemotherapy for high-risk chemo-refractory or relapsed GTN (Cohort B)
- FIGO stages I-III with score 653 or stage IV for Cohort A; prognostic score 657 for Cohort B
- Eastern Cooperative Oncology Group performance status 0-1
- Abnormal serum hCG level (at least 5 IU/L)
- Expected survival of at least 4 months
- Adequate organ function including hemoglobin 6590 g/L, neutrophil count 651.75x10^9/L, platelets 65100x10^9/L, creatinine 651.75x upper limit of normal, urea nitrogen 652.75x upper limit of normal, normal bilirubin and liver enzymes, albumin 6525 g/L, and normal thyroid function
- Female patients of childbearing age must have a negative pregnancy test and agree to use effective contraception during the study and for 6 months after the last drug dose
- Willing and able to provide informed consent
You will not qualify if you...
- Prior treatment with immunotherapy drugs or anti-angiogenic therapies
- Receipt of live vaccines within 4 weeks before starting study drug
- Participation in other antitumor drug trials within 4 weeks before starting study drug
- Other malignancies within the past 3 years
- Use of immunosuppressive drugs within 14 days before starting camrelizumab
- Active or history of autoimmune disease
- Uncontrolled high blood pressure despite treatment
- Significant heart problems including ischemia, heart failure, or arrhythmias
- Abnormal blood clotting or bleeding disorders
- Severe infections or unexplained fever within 4 weeks before starting study drug
- History of psychotropic drug abuse or mental disorders
- Major surgery within 4 weeks before starting study drug
- Conditions affecting oral drug absorption or recent serious intestinal problems
- Significant protein in urine
- HIV infection or active hepatitis B or C infection
- Other reasons as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until completion of treatment, disease progression, unacceptable toxicity, or withdrawal of consent
Participants receive camrelizumab and apatinib combined with chemotherapy according to their cohort assignment. Cohort A participants receive camrelizumab every 2 weeks, daily apatinib, and chemotherapy including low-dose cycles if needed, followed by consolidation chemotherapy and maintenance treatment. Cohort B participants receive camrelizumab every 3 weeks, daily apatinib, and multi-drug chemotherapy until disease progression or unacceptable toxicity.
Regular visits for treatment administration and monitoring according to treatment schedule
Duration - Up to one year
Participants are monitored for response, progression-free survival, overall survival, and safety outcomes for up to one year after treatment initiation.
Periodic visits for assessments and safety monitoring
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yang Xiang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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