Status:
UNKNOWN
H101 Combined With Camrelizumab for Recurrent Cervical Cancer
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Uterine Cervical Neoplasms
Oncolytic Virotherapy
Eligibility:
FEMALE
18-80 years
Phase:
PHASE2
Brief 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 purpo...
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 effe...
Eligibility Criteria
Inclusion
- 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;
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT05234905
Start Date
March 1 2022
End Date
December 1 2024
Last Update
February 10 2022
Active Locations (4)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
2
Jinhua Municipal Central Hospital Medical Group
Jinhua, China
3
Ningbo First Hospital
Ningbo, China
4
Taizhou Central Hospiatl
Taizhou, China