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New treatment option for Gestational Trophoblastic Neoplasia
Official title Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia
ClinicalTrials.gov ID: NCT05139095
What this study is testing
What is Camrelizumab plus apatinib CohortA?
Camrelizumab plus apatinib CohortA is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for gestational trophoblastic neoplasia.
Also referred to as Camrelizumab plus apatinib and multi-drug chemotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, women only
You may be able to join 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...
- Patients with ultra high-risk GTN (FIGO stages I-III: score ≥13 and stage IV) according to the International Federation of Gynecology and Obstetrics...
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
You likely can't join if
- Previous treatment with immunotherapy drugs (including antibodies targeting PD-1, PD-L1, cytotoxic T-lymphocyte-associated protein 4, T-cell...
- 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...
- Abnormal coagulation (international normalised ratio \>1 5×ULN or prothrombin time \>ULN+4 seconds or activated partial thromboplastin time \>1...
See the full eligibility criteria
- 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 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...
- 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...
- 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.
- 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)...
- 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)...
- 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...
- 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...
- 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...
- Other reasons as judged by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.