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Gestational Trophoblastic NeoplasiaPhase 2NCT04812002

Study of PD-1 Antibody and Bevacizumab in the Treatment of High-risk GTN After Combined Chemotherapy

A Phase 2 study testing PD-1 inhibitor， bevacizumab in people with Gestational Trophoblastic Neoplasia, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Gestational trophoblastic Neoplasia（GTN） is a kind of malignant tumor in women of childbearing age. It is easy to metastasized through the blood system in the early stage, so it is a relatively malignant tumor. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Gestational Trophoblastic Neoplasia
What is being tested?
PD-1 inhibitor， bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
15 Apr 2021to 15 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent
  • Clinically diagnosed as recurrent or drug-resistant trophoblastic tumor
  • After treatment with at least two or more multidrug chemotherapy regimens
  • Survival is expected to exceed 3 months
  • Age ≥18 years, age ≤75 years
  • Karnofsky score ≥60分，ECOG score ≤2分
Show all 11Show fewer
  • No serious complications
  • Take effective contraceptives during treatment
  • Patients can be followed up as required
  • Blood test within 3 days: ANC≥1.5×109/L, PT ≥100×109/L, Hb≥90g/L, BIL ≤ 1.5 times of the high limit of normal value, ALT/ALST ≤ 1.5 times of the high limit of normal value, BUN and Cr≤ normal value
  • Coagulation function, thyroid function and myocardial enzyme in the normal range

Who cannot join

  • Previously, he had received anti-PD-1, anti-PD-L1, bevacizumab and other drugs;
  • Within 2 weeks before the first administration, he had received anticancer Chinese patent medicine or immunomodulatory drugs;
  • Within 2 years before the first administration, he had received active autoimmune disease requiring systemic treatment;
  • Were receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to first administration;
  • Clinically uncontrollable pleural effusion/peritoneal effusion is present;
  • Allergic to PD-1 monoantibody, bevacizumab and other active ingredients or excipients；
Show all 11Show fewer
  • Failure to fully recover from toxicity and/or complications；
  • History of HIV infection, untreated active hepatitis B, and active HCV infection subjects；
  • Live vaccine was administered within 30 days prior to the first dose；
  • Patients with serious or uncontrollable medical conditions who are not suitable for chemotherapy；
  • Participating in clinical trials of other drugs at the same time or 4 weeks before the first administration。

Trial locations and contacts

1 site in 1 country.

Xing Xie, phD contact

+8613606705128

panzimin@163.com

Zimin Pan, MD contact

+8613758142505

panzimin@zju.edu.cn

China1 site, 1 recruiting

  • Women's Hospital School of Medicine Zhejiang University

    Hangzhou, Zhejiang, 310000

    Xing Xie, phD

    Recruiting

Other trials in China

About this study

Official title: Phase II Single-arm Clinical Study of PD-1 Antibody and Bevacizumab in the Treatment of Relapsed or Refractory High-risk Gestational Trophoblasitc Neoplasia After Second-line or Above Combined Chemotherapy

Gestational trophoblastic Neoplasia（GTN） is a kind of malignant tumor in women of childbearing age. It is easy to metastasized through the blood system in the early stage, so it is a relatively malignant tumor. The tumor is highly sensitive to chemotherapy, and low-risk patients have good prognosis, with survival rate and cure rate approaching 100%, but high-risk patients are prone to drug resistance, or relapse after remission. For relapsed, refractory, high-risk GTN, multiple remedies have been reported in the literature, but the remission rate is only 75-80%. For relapsed or refractory high-risk GTN, multiple remedies have been reported in the literature, but the remission rate is only 75-80%.

Currently, targeted therapy and immunotherapy are widely used in various refractory solid tumors. For GTN, there are also a number of related studies. In this study, PD-1 inhibitors combined with bevacizumab were used to treat refractory high-risk GTN with relapse or drug resistance after receiving previous second-line or above multidrug combination therapy, to study the efficacy and safety of the treatment regimen.

Read the detailed description

In this study, PD-1 inhibitors combined with bevacizumab were used to treat refractory high-risk trophoblastic tumor (GTN) with relapse or drug resistance after receiving previous two-line or above multidrug combination therapy, and the efficacy and safety of the two drugs were evaluated.

Patients who meet the requirements will sign the informed consent and be enrolled voluntarily. This project is a single-arm study without a control group. Twenty patients are expected to be enrolled, and there are 4 centers competing for enrollment.

All patients received at least two-line multidrug combination therapy, and some patients may have undergone or planned surgery and/or radiation therapy. Through the HCG value and measurable changes in the size of the lesions, we can understand the changes of the disease. The primary endpoints were PFS and ORR Whenever, for whatever reason, the subject does not complete the clinical trial observation, is considered to be an abscission case. When the subject falls off, the researcher must fill in the reason for the fall off in the CRF, and contact the subject as much as possible, complete the items that can be evaluated, and record the time of the last medication to prepare for the analysis of its efficacy and safety. The CRF should be kept for future reference

Being tested
PD-1 inhibitor， bevacizumab
Keywords
bevacizumab, pd-1, chemotherapy
Medical subject headings
Gestational Trophoblastic Disease, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PD-1 inhibitor， bevacizumabDrug

    Also called Camrelizumab for Injection

    Both drugs are given intravenously

Study groups in NCT04812002
Study groupRoleWhat they receive
Double medicine combinedExperimentalparticipants received 200mg of PD-1 inhibitors combined 15mg of bevacizumab per square body surface area intravenously every 3 weeks
Receives: Drug: PD-1 inhibitor， bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

    PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first.

    Measured: From date of randomization until the date of first documented progression or death from any cause, whichever occurred first, or last follow-up for patients alive without progression, assessed up to approximately 24 months

Secondary outcomes (1)

  1. ORR

    ORR is defined as the rate of CR or PR.Partial response (PR) is defined as a reduction of HCG by 50% or more from the starting value in continuous measurements; Complete response (CR) is defined as HCG normalization of continuous measurements at least two weeks intervals.

    Measured: From date of randomization until PD or death from any cause, assessed up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2021
  2. Study start15 Apr 2021
  3. Primary completion15 Apr 2024 (estimated)
  4. Study completion15 Apr 2026 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04812002
Sponsor's protocol ID
CSEM018
Status last verified
Jun 2022
First submitted
21 Mar 2021
Last updated
3 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lurain JR, Singh DK, Schink JC. Primary treatment of metastatic high-risk gestational trophoblastic neoplasia with EMA-CO chemotherapy. J Reprod Med. 2006 Oct;51(10):767-72.

    PubMed 17086804

  • Alifrangis C, Agarwal R, Short D, Fisher RA, Sebire NJ, Harvey R, Savage PM, Seckl MJ. EMA/CO for high-risk gestational trophoblastic neoplasia: good outcomes with induction low-dose etoposide-cisplatin and genetic analysis. J Clin Oncol. 2013 Jan 10;31(2):280-6. doi: 10.1200/JCO.2012.43.1817. Epub 2012 Dec 10.

    PubMed 23233709

  • Li J, Yue H, Wang X, Chen R, Lu X. Chemotherapy for gestational trophoblastic neoplasia patients with a FIGO score of 12 or greater: A multistudy analysis. Eur J Obstet Gynecol Reprod Biol. 2019 Jul;238:164-169. doi: 10.1016/j.ejogrb.2019.05.023. Epub 2019 May 20.

    PubMed 31136884

  • Anantharaju AA, Pallavi VR, Bafna UD, Rathod PS, R VC, K S, Kundargi R. Role of salvage therapy in chemo resistant or recurrent high-risk gestational trophoblastic neoplasm. Int J Gynecol Cancer. 2019 Mar;29(3):547-553. doi: 10.1136/ijgc-2018-000050. Epub 2019 Jan 29.

    PubMed 30700567

  • Bianconi MI, Otero S, Storino C, Jankilevich G. Role of Capecitabine in the Management of Gestational Trophoblastic Neoplasia: A Drug for Two Settings. J Reprod Med. 2017 May-Jun;62(5-6):250-6.

    PubMed 30027717

  • Wang J, Short D, Sebire NJ, Lindsay I, Newlands ES, Schmid P, Savage PM, Seckl MJ. Salvage chemotherapy of relapsed or high-risk gestational trophoblastic neoplasia (GTN) with paclitaxel/cisplatin alternating with paclitaxel/etoposide (TP/TE). Ann Oncol. 2008 Sep;19(9):1578-83. doi: 10.1093/annonc/mdn181. Epub 2008 May 2.

    PubMed 18453518

  • Bolze PA, Patrier S, Massardier J, Hajri T, Abbas F, Schott AM, Allias F, Devouassoux-Shisheboran M, Freyer G, Golfier F, You B. PD-L1 Expression in Premalignant and Malignant Trophoblasts From Gestational Trophoblastic Diseases Is Ubiquitous and Independent of Clinical Outcomes. Int J Gynecol Cancer. 2017 Mar;27(3):554-561. doi: 10.1097/IGC.0000000000000892.

    PubMed 28060141

  • Veras E, Kurman RJ, Wang TL, Shih IM. PD-L1 Expression in Human Placentas and Gestational Trophoblastic Diseases. Int J Gynecol Pathol. 2017 Mar;36(2):146-153. doi: 10.1097/PGP.0000000000000305.

    PubMed 27362903

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD-1 inhibitor， bevacizumab in people with Gestational Trophoblastic Neoplasia, run by Women's Hospital School Of Medicine Zhejiang University 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 11 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: status not confirmed, as of the sponsor's last update on 3 Jun 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xing Xie, phD (+8613606705128, panzimin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: From date of randomization until the date of first documented progression or death from any cause, whichever occurred first, or last follow-up for patients alive without progression, assessed up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04812002, which also lists 8 linked publications.

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 Jun 2022.

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