A Phase 3 interventional study of Etoposide and actinomycin D in Gestational Trophoblastic Neoplasms, sponsored by Weiguo Lv. Recruiting at 1 site in China. Open to female participants aged Up to 60 Years. Per ClinicalTrials.gov, last updated 2022-06-03.
Sponsored by Weiguo Lv · Phase 3, Interventional, and Treatment
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Among 12 studies in Gestational Trophoblastic Disease with a site in China — 8 open to participants now, 9 under way, 1 of them phase 3. Gestational Trophoblastic Disease · China.
Among the 12 studies in Gestational Trophoblastic Disease with a site in China, this one is the 4th largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2016, is one of 2 in phase 3, and was the 2nd registered.
57 studies on the registry are indexed under Gestational Trophoblastic Disease; 16 are open to participants now.
Browse Gestational Trophoblastic Disease studies →8 of the 12 studies in Gestational Trophoblastic Disease with a site in China are open now. Recruiting first, the newest first:
Peking Union Medical College Hospital · Sites in China
Ages 18–60 · Women only
Women's Hospital School Of Medicine Zhejiang University · Sites in China
Ages 18+ · Women only
Peking Union Medical College Hospital · Sites in China
Ages 18–60 · Women only
Peking Union Medical College Hospital · Sites in China
Ages 18–60 · Women only
Women's Hospital School Of Medicine Zhejiang University · Sites in China
Ages 18–75 · Women only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 14 Gestational Trophoblastic Disease studies recruiting now, 6 (43%) set no upper age limit and 8 (57%) stop at 75 or younger; 6 take children under 18; none take healthy volunteers.
This study: Up to 60 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 6 · Phase 3 3
First in 2012; this study’s year is marked. 1 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 214 is above the median of 40 across 35 interventional studies indexed under Gestational Trophoblastic Disease.
Median enrollment 70 across the 11 interventional studies, 1,000 across the 1 observational. Of the 1 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 12 has an industry lead sponsor. The 5 most frequent:
This is the only study on the registry with Weiguo Lv as lead sponsor.
Weiguo Lv has 1 study filed under Gestational Trophoblastic Disease — fewer than ten, so there is no comparison to draw.
2 of the studies in Gestational Trophoblastic Disease with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05139095Peking Union Medical College HospitalCamrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia | 2026-12-01 |
| NCT03703271Women's Hospital School Of Medicine Zhejiang UniversityStudy of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia | 2026-12-31 |
Add all 2 to your calendar (.ics) → With an account.
Among the 12 studies in Gestational Trophoblastic Disease with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This clinical trial is designed to study the effect and safety of paclitaxel plus cisplatin as the first-line regimen in the treatment of high risk gestational trophoblastic tumor.
Gestational trophoblastic tumor (GTN) is a group of malignant tumors derived from placental trophoblastic cells, most of which occur in women of reproductive age. The survival rate of patients with score of 7 or more points, or WHO Ⅳ period for high-risk patients was of 60% to 80%. However, due to severe toxic reactions, long treatment time, loss of optimal reproductive age and increased costs, and treatment failure caused by chemotherapy resistance, high-risk GTN is still one of the tumors seriously affecting the life health and quality of life of young women.
First-line chemotherapy recommended by FIGO is regimen of EMA - CO with corresponding side effects and adverse factors in the following aspects as relatively higer incidence of myelosupression, VP - 16 being associated with a second tumor, especially leukemia, and a definite effect of cyclophosphamide on the failure ovarian function Taxol (Taxol) is the most widely used and most effective broad-spectrum anti-tumor drug in gynecological malignant tumors at present, and T (paclitaxel) +P (platinum drugs) scheme is the first-line chemotherapy scheme in ovarian cancer patients at present. According to references, TP also has effects on resistant and refactory high risk GTN patients.
Given relatively simple operation way of TP chemotherapy, and the effect of chemotherapy in recurrence and high-risk refractory GTN performance,this prospective multicenter randomized controlled clinical research was to study the effect and safety of paclitaxel plus cisplatin as the first-line regimen in the treatment of high risk gestational trophoblastic tumor compared with EMA-CO.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
etoposide, methotrexate ,actinomycin D,vincristine, cyclophosphamide(EMA-CO), two weeks a cycle
Drug: Etoposide · Drug: actinomycin D · Drug: methotrexate · Drug: vincristine · Drug: cyclophosphamide
paclitaxel + cisplatin or carboplatin，two weeks a cycle
Drug: Paclitaxel · Drug: Cisplatin · Drug: Carboplatin
etoposide 100mg/m2 ivgtt started at the first day of cycle, two weeks a cycle
Also known as: VP-16
actinomycin D 500ug ivgtt, started at the first day of cycle, two weeks a cycle
Also known as: ACTD, Sanamycin
methotrexate 100mg/m2, 200mg/m2, ivgtt, tetrahydrofolic acid （FA) 15mg q12h\*4(24h after methotrexate injection),started at the first day of cycle, two weeks a cycle
Also known as: MTX
vincristine 1mg/m2 started at the 8th day of cycle, two weeks a cycle
Also known as: VCR
cyclophosphamide 600mg/m2, started at the 8th day of cycle, two weeks a cycle
Also known as: CTX
paclitaxel 135mg/m2, started at the first day of cycle, two weeks a cycle
Also known as: Taxol
cisplatin 50mg/m2, started at the first day of cycle, two weeks a cycle
Also known as: DDP
carboplatin area under curve (AUC)=4-5, started at the first day of cycle, two weeks a cycle,as a substitute drug for cisplatin
Also known as: CBP
complete remission rate in firstline treatment
We may calculate the rate of complete response and the rate of treatment failure at the preliminary end point of the trail.
Time frame: 3 years
Severity of adverse events as assessed by the WHO
We calculate the adverse events during and after chemotherapy.
Time frame: 3 years
Overall Survival Rate (OR)
We calculate the overall survival rate of high risk GTN patients after chemotherapy.
Time frame: 3 years
Ovarian functional evaluation
We may test serum level of anti-mullerian hormone (AMH) every 6 months and the time of menstrual cycle resuming after chemotherapy.
Time frame: every 6 months up to 3 years
The pregnancy rate
To calculate the pregnancy rate in an actuarial manner using the Kaplan-Meier method at the end of the trail
Time frame: 3 years
Started Mar 2016 (actual). Primary completion is estimated for Mar 2024, 96 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Paclitaxel · Cisplatin
Gestational Trophoblastic Disease →