CompletedPhase 2

Camrelizumab Combined With Apatinib for Recurrent Resistant GTN

China20 participantsStarted 2019-08-08

Plain-language summary

This study is to evaluate the efficacy and safety of camrelizumab plus apatinib in patients with high-risk chemo-refractory or relapsed GTN.

Who can participate

Age range

18 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients with recurrent resistant GTN previously received twice or more combination chemotherapy before enrolment;
. In the 20000 FIGO staging and classification, a risk score of 7 and above 7 (Considered high risk) or resistant recurrent placental site trophoblastic tumor or resistant recurrent epithelial trophoblastic tumor;
. Aged 18-70 years;
. An Eastern Cooperative Oncology Group performance status of 0-2;
. abnormal serum HCG level;
. Expected survival ≥ 4 months;
. The function of vital organs meets the following requirements： Hemoglobin≥80g/L; Absolute neutrophil count≥1.5\*109/L；Platelets≥100
. Female subjects of childbearing age must exclude pregnancy and are willing to use a medically approved high-efficiency contraceptive (eg, IUD, contraceptive or condom) during the study period and within 3 months of the last study drug administration.

Exclusion criteria

. Previously exposed to other anti-angiogenic small-molecule TKI drugs, such as pazopanib, sorafenib, regorafenib, cilnitraz, etc. or anti-angiogenic mAbs such as bevacizumab ; or had used an anti-PD-1 antibody, an anti-CTLA-4 antibody, TCR-T, CAR-T and other immune therapy; or 4 weeks before the first administration participated in any other clinical trials of anticancer drugs; or before the first dose Live attenuated vaccines are accepted within 4 weeks or during the study period.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ORR(objective response rate)

Timeframe: Up to one years

Trial details

NCT IDNCT04047017

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-18

View on ClinicalTrials.gov More Gestational Trophoblastic Disease trials