Gestational Trophoblastic NeoplasiaPhase 2NCT05139095
Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia
A Phase 2 study testing Camrelizumab plus apatinib CohortA and Camrelizumab plus apatinib Cohort B in people with Gestational Trophoblastic Neoplasia, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Gestational Trophoblastic Neoplasia
- What is being tested?
- Camrelizumab plus apatinib CohortA and Camrelizumab plus apatinib Cohort B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 27 Jan 2022to 1 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
xiang yang
About this study
Official title: Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia: a Cohort, Open-label, Phase 2 Trial
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.
Read the detailed description
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).
Cohort A: Eligible patients will receive camrelizumab (200mg q2w iv) plus apatinib (250 mg qd po) plus chemotherapy. After normalization of serum β-human chorionic gonadotropin (β-hCG) levels, patients will receive 4 cycles of consolidation chemotherapy combined with camrelizumab plus apatinib and then 6 months of camrelizumab plus apatinib as maintenance treatment. Treatment will be continued until completion of treatment, disease progression, unacceptable toxicity, or withdrawal of consent.The primary endpoint is complete remission rate (the proportion of patients achieving complete remission). Secondary endpoints include objective response rate (the proportion of patients achieving complete remission and partial remission), progression-free survival (time from the treatment initiation to disease progression or death, whichever comes first), overall survival (time from the treatment initiation to the date of death or last follow-up), duration of response (time from the first evidence of response to disease progression or death, whichever comes first) and safety.
Cohort B: Eligible patients will receive camrelizumab (200mg q3w iv) plus apatinib (250 mg qd po) plus chemotherapy. Treatment will be continued until disease progression, unacceptable toxicity, or withdrawal of consent.After the first normalization of serum β-hCG, combination treatment was continued during the 4-week confirmation period for complete response. Once complete response was confirmed, patients received an additional 3-4 cycles of consolidation therapy, followed by 6 months of maintenance therapy with camrelizumab plus apatinib. The primary endpoint is objective response rate. Secondary endpoints include progression-free survival, duration of response, overall survival and safety.
- Conditions
- Gestational Trophoblastic Neoplasia
- Being tested
- Camrelizumab plus apatinib CohortA, Camrelizumab plus apatinib Cohort B
- Medical subject headings
- Gestational Trophoblastic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab plus apatinib CohortADrug
Also called Camrelizumab plus apatinib and multi-drug chemotherapy
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 BDrug
Also called Camrelizumab plus apatinib and multi-drug chemotherapy
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 group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Population: ultra high-risk gestational trophoblastic neoplasia Receives: Drug: Camrelizumab plus apatinib CohortA |
| Cohort B | Experimental | Population: high-risk chemo-refractory or relapsed gestational trophoblastic neoplasia Receives: Drug: Camrelizumab plus apatinib Cohort B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to one year
Secondary outcomes (9)
Cohort A: Objective response rate
The proportion of patients with complete or partial response according to serum β-hCG level.
Measured: up to one year
Cohort A: Progression-free survival
The time from the treatment initiation to disease progression or death, whichever comes first. Disease progression is defined as any increase in serum β-hCG level from baseline after 2 cycles of treatment or the presence of new metastatic lesions.
Measured: up to one year
Cohort A: Overall survival
The time from the treatment initiation to the date of death or last follow-up.
Measured: up to one year
Cohort A: Duration of response
The time from the first evidence of response to disease progression or death, whichever comes first.
Measured: up to one year
Cohort A: Frequency and severity of adverse events
Determine frequency and severity of adverse events as assessed by NCI CTCAE (Version 5.0) which is used to evaluate the grade of adverse events, to observe any adverse event and serious adverse event that occurred in all patients during the clinical study period, including abnormal laboratory examination results, clinical manifestations and vital signs, to record their clinical manifestation characteristics, severity, occurrence time, duration, corresponding treatment and prognosis, and to determine their relationship with the study drug.
Measured: up to one year
Cohort B: Progression-free survival
The time from the treatment initiation to disease progression or death, whichever comes first.
Measured: up to one year
Cohort B: Duration of response
The time from the first evidence of response to disease progression or death, whichever comes first.
Measured: up to one year
Cohort B: Overall survival
The time from the treatment initiation to the date of death or last follow-up.
Measured: up to one year
Cohort B: Frequency and severity of adverse events
Determine frequency and severity of adverse events as assessed by NCI CTCAE (Version 5.0) .
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start27 Jan 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Trophoblastic NeoplasiaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139095
- Sponsor's protocol ID
- MA-GTN-II-001
- Status last verified
- Apr 2026
- First submitted
- 6 Nov 2021
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia: a Cohort, Open-label, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT05139095
- Acronym / sponsor ID
- MA-GTN-II-001
- Conditions
- Gestational Trophoblastic Neoplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Cohort A: Eligible patients will receive camrelizumab (200mg q2w iv) plus apatinib (250 mg qd po) plus chemotherapy. After normalization of serum β-human chorionic gonadotropin (β-hCG) levels, patients will receive 4 cycles of consolidation chemotherapy combined with camrelizumab plus apatinib and then 6 months of camrelizumab plus apatinib as maintenance treatment. Treatment will be continued until completion of treatment, disease progression, unacceptable toxicity, or withdrawal of consent.The primary endpoint is complete remission rate (the proportion of patients achieving complete remission). Secondary endpoints include objective response rate (the proportion of patients achieving complete remission and partial remission), progression-free survival (time from the treatment initiation to disease progression or death, whichever comes first), overall survival (time from the treatment initiation to the date of death or last follow-up), duration of response (time from the first evidence of response to disease progression or death, whichever comes first) and safety.
Cohort B: Eligible patients will receive camrelizumab (200mg q3w iv) plus apatinib (250 mg qd po) plus chemotherapy. Treatment will be continued until disease progression, unacceptable toxicity, or withdrawal of consent.After the first normalization of serum β-hCG, combination treatment was continued during the 4-week confirmation period for complete response. Once complete response was confirmed, patients received an additional 3-4 cycles of consolidation therapy, followed by 6 months of maintenance therapy with camrelizumab plus apatinib. The primary endpoint is objective response rate. Secondary endpoints include progression-free survival, duration of response, overall survival and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Camrelizumab plus apatinib CohortAPopulation: ultra high-risk gestational trophoblastic neoplasia |
| Cohort B | Experimental | Drug: Camrelizumab plus apatinib Cohort BPopulation: high-risk chemo-refractory or relapsed gestational trophoblastic neoplasia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camrelizumab plus apatinib CohortAAlso: Camrelizumab plus apatinib and multi-drug chemotherapyCamrelizumab (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). | Drug | Cohort A |
| Camrelizumab plus apatinib Cohort BAlso: Camrelizumab plus apatinib and multi-drug chemotherapyCohort 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. | Drug | Cohort B |
Primary outcome
Cohort A: Complete remission rate
Time frame: up to one year
The proportion of patients achieving complete remission. Complete remission is defined as normal serum β-hCG level measured for 3 consecutive weeks.
Cohort B: Objective response rate
Time frame: up to one year
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.
9 secondary outcomes
Cohort A: Objective response rate
Time frame: up to one year
Cohort A: Progression-free survival
Time frame: up to one year
Cohort A: Overall survival
Time frame: up to one year
Cohort A: Duration of response
Time frame: up to one year
Cohort A: Frequency and severity of adverse events
Time frame: up to one year
Cohort B: Progression-free survival
Time frame: up to one year
Cohort B: Duration of response
Time frame: up to one year
Cohort B: Overall survival
Time frame: up to one year
Cohort B: Frequency and severity of adverse events
Time frame: up to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab plus apatinib CohortA and Camrelizumab plus apatinib Cohort B in people with Gestational Trophoblastic Neoplasia, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Xiang (010-69156068, XiangY@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort A: Complete remission rate (time frame: up to one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.