H101 Combined With Camrelizumab for Recurrent Cervical Cancer

NCT05234905 | Unknown Phase 2

• 1 other identifier: CARTOnG 2105
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 4

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 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).

Conditions

Uterine Cervical Neoplasms; Oncolytic Virotherapy; Camrelizumab

Keywords

Recurrent cervical cancer; H101; Camrelizumab; Objective response rate

Outcome Measures

Primary Outcomes (1)

• ORR(Objective Response Rate)

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

  2 years

Secondary Outcomes (3)

• PFS(Progression Free Survival)

  2 years

• DCR(Disease Control Rate)

  2 years

• OS(Overall Survival)

  2 years

Study Arms (1)

Recombinant human adenovirus type 5+ Camrelizumab

EXPERIMENTAL

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.

Drug: Recombinant human adenovirus type 5＋Camrelizumab

Interventions

Recombinant human adenovirus type 5＋Camrelizumab DRUG

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.

Also known as: H101＋Camrelizumab

Recombinant human adenovirus type 5+ Camrelizumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants voluntarily participated in this study and signed the informed consent;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (4)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Jinhua Municipal Central Hospital Medical Group

Jinhua, China

Location

Ningbo First Hospital

Ningbo, China

Location

Taizhou Central Hospiatl

Taizhou, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Xiang Zhang

  Zhejiang Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiang Zhang

CONTACT

15988109696; zhangxiang@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 10, 2022
• Study Start: March 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2024
• Last Updated: February 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)