H101 Combined With Camrelizumab for Recurrent Cervical Cancer

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Female

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%. 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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital

Criteria

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.