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H101 Combined With Camrelizumab for Recurrent Cervical Cancer

8 februari 2022 bijgewerkt door: 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).

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

  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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

55

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: 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.

Andere namen:
  • H101＋Camrelizumab

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
ORR(Objective Response Rate)
Tijdsspanne: 2 years
The proportion of CR(complete response) and PR(partial response) in all patients.
2 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
PFS(Progression Free Survival)
Tijdsspanne: 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)
Tijdsspanne: 2 years
The proportion of CR(complete response), PR(partial response) and SD(stable disease) in all patients.
2 years
OS(Overall Survival)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Zhejiang Cancer Hospital

Onderzoekers

  • Studie directeur: Xiang Zhang, Zhejiang Cancer Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

1 maart 2022

Primaire voltooiing (Verwacht)

1 juni 2023

Studie voltooiing (Verwacht)

1 december 2024

Studieregistratiedata

Eerst ingediend

27 januari 2022

Eerst ingediend dat voldeed aan de QC-criteria

8 februari 2022

Eerst geplaatst (Werkelijk)

10 februari 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 februari 2022

Laatste update ingediend die voldeed aan QC-criteria

8 februari 2022

Laatst geverifieerd

1 december 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CARTOnG 2105

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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