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

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.

Aperçu de l'étude

Statut

Recrutement

Description détaillée

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

Type d'étude

Interventionnel

Inscription (Anticipé)

20

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Xing Xie, phD
  • Numéro de téléphone: +8613606705128
  • E-mail: panzimin@163.com

Sauvegarde des contacts de l'étude

Lieux d'étude

    • Zhejiang
      • Hangzhou, Zhejiang, Chine, 310000
        • Recrutement
        • Women'S Hospital School of Medicine Zhejiang University
        • Contact:
          • Xing Xie, phD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  1. Signed Informed Consent
  2. Clinically diagnosed as recurrent or drug-resistant trophoblastic tumor
  3. After treatment with at least two or more multidrug chemotherapy regimens
  4. Survival is expected to exceed 3 months
  5. Age ≥18 years, age ≤75 years
  6. Karnofsky score ≥60分,ECOG score ≤2分
  7. No serious complications
  8. Take effective contraceptives during treatment
  9. Patients can be followed up as required
  10. 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
  11. Coagulation function, thyroid function and myocardial enzyme in the normal range

Exclusion Criteria:

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Double medicine combined
participants received 200mg of PD-1 inhibitors combined 15mg of bevacizumab per square body surface area intravenously every 3 weeks
Both drugs are given intravenously
Autres noms:
  • Camrelizumab pour injection

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
PFS
Délai: 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
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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
ORR
Délai: From date of randomization until PD or death from any cause, assessed up to 24 months
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.
From date of randomization until PD or death from any cause, assessed up to 24 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Xing Xie, doctor, Women'S Hospital School of Medicine Zhejiang University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 avril 2021

Achèvement primaire (Anticipé)

15 avril 2024

Achèvement de l'étude (Anticipé)

15 avril 2026

Dates d'inscription aux études

Première soumission

21 mars 2021

Première soumission répondant aux critères de contrôle qualité

22 mars 2021

Première publication (Réel)

23 mars 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 juin 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 juin 2022

Dernière vérification

1 juin 2022

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur PD-1 inhibitor, bevacizumab

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