Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

H101 Combined With Camrelizumab for Recurrent Cervical Cancer

8 febbraio 2022 aggiornato da: Zhejiang Cancer Hospital

Oncolytic Virus(H101) Combined With Camrelizumab for Recurrent Cervical Cancer: a Prospective, Multicenter Study

There is no standard treatment for recurrent cervical cancer that progresses or persists after first-line treatment. The objective response rate of anti-PD-1 antibody treatment is about 15%. The purpose of this study was to evaluate whether the regimen could improve the objective response rate by intratumoral injection of oncolytic virus(recombinant human adenovirus type 5 injection, H101) combined with anti-PD-1 antibody(camrelizumab).

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

  1. Main research purpose To evaluate the efficacy of H101 combined with camrelizumab in patients with incurable recurrent cervical cancer.

  2. Secondary research purpose To evaluate other curative effects of H101 combined with camrelizumab in patients with incurable recurrent cervical cancer.

    To evaluate the safety of H101 combined with camrelizumab in patients with incurable recurrent cervical cancer.

  3. Purpose of Exploratory Research To explore the changes of tumor microenvironment before and after H101 injection and the mechanism of action in combination with PD-1, and to accurately screen the beneficiaries based on molecular expression.

  4. Overall experimental design This study is a multicenter, prospective, clinical study to investigate the efficacy and safety of H101 combined with camrelizumab in the treatment of incurable recurrent cervical cancer patients. It is expected that 55 subjects will be enrolled.

    The study was divided into 5 phases: screening period, baseline period, treatment period, and follow-up period. Patients with recurrent cervical cancer who were eligible for inclusion and were incurable by previous first-line treatment were screened. During the follow-up period, follow-up was conducted every 1 month for at least 2 years.

  5. Subject population The target population of this study was patients with recurrent cervical squamous cell carcinoma/adenocarcinoma/adenosquamous carcinoma who were incurable after first-line therapy.
  6. Treatment allocation All subjects enrolled in this study received H101 combined with camrelizumab.
  7. Drug dosage and administration in the trial Dosing regimen: H101 + camrelizumab. 1) H101: 1 lesion was selected for intratumoral injection. Intratumoral injection of H101 was used on the 1st and 4th day of each cycle, repeated once in 3 weeks. H101 dosage: Tumor maximum diameter ≤5 cm, 1.5×10^12vp (3 injections) on day 1 and 1.0×10^12vp (2 injections) on day 4.

Tumor maximum diameter >5cm but ≤10cm, 3.0×10^12vp (6 injections) on day 1, 2.0×10^12vp (4 injections) on day 4.

Tumor maximum diameter >10cm, 4.5×10^12vp (9 injections) on day 1 and 3.0×10^12vp (6 injections) on day 4.

H101 will be used until injected lesion disappears or 5 cycles, whichever occurs first.

2) Camrelizumab: 200 mg intravenously. Dosing after H101 on day 1 of each cycle, repeated 3 weeks. The drug was discontinued or discontinued for 2 years until the patient developed tumor progression or intolerable toxicity.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

55

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
      • Jinhua, Cina
        • Jinhua Municipal Central Hospital Medical Group
      • Ningbo, Cina
        • Ningbo First Hospital
      • Taizhou, Cina
        • Taizhou Central Hospiatl
    • Zhejiang
      • Hangzhou, Zhejiang, Cina, 310022
        • Zhejiang Cancer Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

All of the following criteria must be met for inclusion:

  1. Participants voluntarily participated in this study and signed the informed consent;
  2. 18-80 years old;
  3. Cervical squamous cell carcinoma/adenocarcinoma/adenosquamous carcinoma;
  4. Participants with incurable recurrence after first-line treatment or participants with incurable recurrence within the irradiation field;
  5. At least one lesion that meets RICIST 1.1 criteria can be evaluated and can be injected intratumorally;
  6. ECOG score 0-2 points;
  7. Expected survival > 3 months;
  8. Women of childbearing age must undergo a pregnancy test (serum or urine) before enrollment, and the result is negative, and they are willing to use appropriate methods of contraception during the trial;
  9. Those who can tolerate and comply with the trial protocol, as determined by the investigator.

Exclusion Criteria:

Those who have one of the following conditions should be excluded and cannot be selected:

  1. There is an infection at the intended injection site;
  2. Liver cirrhosis, decompensated liver disease;
  3. Have a history of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency diseases;
  4. Chronic renal insufficiency and renal failure;
  5. Combined with other malignant tumor patients who still need treatment and/or newly diagnosed within 5 years;
  6. Myocardial infarction, severe arrhythmia and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification);
  7. Complications, need to take drugs with serious liver and kidney damage during treatment, such as tuberculosis;
  8. Previous use of anti-PD-1 drugs or oncolytic viruses;
  9. Patients who cannot understand the experimental content and cannot cooperate and those who refuse to sign the informed consent;
  10. Those with concomitant diseases or other special conditions that seriously endanger the safety of patients or affect the completion of the study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Recombinant human adenovirus type 5+ Camrelizumab

Recombinant human adenovirus type 5: one lesion was selected for intratumoral injection.Intratumoral injection of H101 was performed on day 1 and day 4 of each cycle, and was repeated once every 3 weeks. H101 dose:

① Tumor maximum diameter ≤5cm, 1.5×10^12vp (3 injections) on day 1, 1.0×10^12vp (2 injections) on day 4.

② Tumor maximum diameter >5cm but ≤10cm, 3.0×10^12vp (6 injections) on day 1 and 2.0×10^12vp (4 injections) on day 4.

③ Tumor maximum diameter >10cm, 4.5×10^12vp (9 injections) on day 1 and 3.0×10^12vp (6 injections) on day 4.

H101 intratumoral injection until the tumor is completely regressed to stop the drug, but not more than 5 cycles at most.

Camrelizumab: administered after H101 on day 1 of each cycle and repeated for 3 weeks. Camrelizumab dose: 200 mg IV.
Droga: Recombinant human adenovirus type 5＋Camrelizumab

Recombinant human adenovirus type 5: one lesion was selected for intratumoral injection.Intratumoral injection of H101 was performed on day 1 and day 4 of each cycle, and was repeated once every 3 weeks. H101 dose:

① Tumor maximum diameter ≤5cm, 1.5×1012vp (3 injections) on day 1, 1.0×1012vp (2 injections) on day 4.

② Tumor maximum diameter >5cm but ≤10cm, 3.0×1012vp (6 injections) on day 1 and 2.0×1012vp (4 injections) on day 4.

③ Tumor maximum diameter >10cm, 4.5×1012vp (9 injections) on day 1 and 3.0×1012vp (6 injections) on day 4.

H101 intratumoral injection until the tumor is completely regressed to stop the drug, but not more than 5 cycles at most.

Camrelizumab: administered after H101 on day 1 of each cycle and repeated for 3 weeks. Camrelizumab dose: 200 mg IV.

Altri nomi:
  • H101＋Camrelizumab

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
ORR(Objective Response Rate)
Lasso di tempo: 2 years
The proportion of CR(complete response) and PR(partial response) in all patients.
2 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
PFS(Progression Free Survival)
Lasso di tempo: 2 years
Refers to the time from the first treatment day to the first occurrence of disease progression or death from any cause (whichever occurs first), and the end point event is determined by the investigator according to RECIST v1.1.
2 years
DCR(Disease Control Rate)
Lasso di tempo: 2 years
The proportion of CR(complete response), PR(partial response) and SD(stable disease) in all patients.
2 years
OS(Overall Survival)
Lasso di tempo: 2 years
Time between the date of randomization grouping and death from any cause or the end of the last follow-up visit.
2 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Zhejiang Cancer Hospital

Investigatori

  • Direttore dello studio: Xiang Zhang, Zhejiang Cancer Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 marzo 2022

Completamento primario (Anticipato)

1 giugno 2023

Completamento dello studio (Anticipato)

1 dicembre 2024

Date di iscrizione allo studio

Primo inviato

27 gennaio 2022

Primo inviato che soddisfa i criteri di controllo qualità

8 febbraio 2022

Primo Inserito (Effettivo)

10 febbraio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 febbraio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 febbraio 2022

Ultimo verificato

1 dicembre 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CARTOnG 2105

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi