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

NCT04812002 | Recruiting Phase 2

• 1 other identifier: CSEM018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gestational Trophoblastic Neoplasia

Keywords

bevacizumab; pd-1; chemotherapy

Outcome Measures

Primary Outcomes (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.

  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)

• ORR

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

Study Arms (1)

Double medicine combined

EXPERIMENTAL

participants received 200mg of PD-1 inhibitors combined 15mg of bevacizumab per square body surface area intravenously every 3 weeks

Drug: PD-1 inhibitor， bevacizumab

Interventions

PD-1 inhibitor， bevacizumab DRUG

Both drugs are given intravenously

Also known as: Camrelizumab for Injection

Double medicine combined

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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；
• 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。

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 17086804 BACKGROUND

• 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.

  PMID: 23233709 BACKGROUND

• 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.

  PMID: 31136884 BACKGROUND

• 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.

  PMID: 30700567 BACKGROUND

• 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.

  PMID: 30027717 BACKGROUND

• 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.

  PMID: 18453518 BACKGROUND

• 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.

  PMID: 28060141 BACKGROUND

• 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.

  PMID: 27362903 BACKGROUND

MeSH Terms

Conditions

Gestational Trophoblastic Disease; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

camrelizumab; Injections

Condition Hierarchy (Ancestors)

Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Xing Xie, doctor

  Women's Hospital School Of Medicine Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xing Xie, phD

CONTACT

+8613606705128; panzimin@163.com

Zimin Pan, MD

CONTACT

+8613758142505; panzimin@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: March 23, 2021
• Study Start: April 15, 2021
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2026
• Last Updated: June 3, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)