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AzTrials

Uterine Cervical NeoplasmsPhase 2NCT05234905

H101 Combined With Camrelizumab for Recurrent Cervical Cancer

A Phase 2 study testing Recombinant human adenovirus type 5＋Camrelizumab in people with Uterine Cervical Neoplasms and Oncolytic Virotherapy, run by Zhejiang Cancer Hospital at 4 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

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%. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
What is being tested?
Recombinant human adenovirus type 5＋Camrelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
4 sitesChina
Study dates
Mar 2022to Dec 2024
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 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All of the following criteria must be met for inclusion:
  • Participants voluntarily participated in this study and signed the informed consent;
  • 18-80 years old;
  • Cervical squamous cell carcinoma/adenocarcinoma/adenosquamous carcinoma;
  • Participants with incurable recurrence after first-line treatment or participants with incurable recurrence within the irradiation field;
  • At least one lesion that meets RICIST 1.1 criteria can be evaluated and can be injected intratumorally;
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  • ECOG score 0-2 points;
  • Expected survival > 3 months;
  • 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;
  • Those who can tolerate and comply with the trial protocol, as determined by the investigator.

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Xiang Zhang contact

15988109696

zhangxiang@zjcc.org.cn

China4 sites

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Jinhua Municipal Central Hospital Medical Group

    Jinhua

  • Ningbo First Hospital

    Ningbo

  • Taizhou Central Hospiatl

    Taizhou

Other trials in China

About this study

Official title: 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).

Read the detailed description
  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.

  1. 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.
Being tested
Recombinant human adenovirus type 5＋Camrelizumab
Keywords
Recurrent cervical cancer, H101, Camrelizumab, Objective response rate
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

  • Recombinant human adenovirus type 5＋CamrelizumabDrug

    Also called H101＋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.

Study groups in NCT05234905
Study groupRoleWhat they receive
Recombinant human adenovirus type 5+ CamrelizumabExperimentalRecombinant 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.
Receives: Drug: Recombinant human adenovirus type 5＋Camrelizumab

What is being measured

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

  1. ORR(Objective Response Rate)

    The proportion of CR(complete response) and PR(partial response) in all patients.

    Measured: 2 years

Secondary outcomes (3)

  1. PFS(Progression Free Survival)

    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.

    Measured: 2 years

  2. DCR(Disease Control Rate)

    The proportion of CR(complete response), PR(partial response) and SD(stable disease) in all patients.

    Measured: 2 years

  3. OS(Overall Survival)

    Time between the date of randomization grouping and death from any cause or the end of the last follow-up visit.

    Measured: 2 years

Timeline

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

  1. First posted10 Feb 2022
  2. Study startMar 2022 (estimated)
  3. Primary completionJun 2023 (estimated)
  4. Study completionDec 2024 (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
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05234905
Sponsor's protocol ID
CARTOnG 2105
Status last verified
Dec 2021
First submitted
27 Jan 2022
Last updated
10 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant human adenovirus type 5＋Camrelizumab in people with Uterine Cervical Neoplasms and Oncolytic Virotherapy, run by Zhejiang Cancer Hospital at 4 sites 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 10 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 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 Xiang Zhang (15988109696, zhangxiang@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR(Objective Response Rate) (time frame: 2 years). 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 NCT05234905.

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 10 Feb 2022.

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