Clinical trial · Interventional
H101 Combined With Camrelizumab for Recurrent Cervical Cancer
Oncolytic Virus(H101) Combined With Camrelizumab for Recurrent Cervical Cancer: a Prospective, Multicenter Study
NCT05234905CI-TRIAL-00056470unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Camrelizumab | — | UNRESOLVED | — |
| Oncolytic Virotherapy | — | UNRESOLVED | — |
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant human adenovirus type 5＋Camrelizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Recombinant human adenovirus type 5+ Camrelizumab
- description
- 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.
- interventionNames
- Drug: Recombinant human adenovirus type 5＋Camrelizumab
Primary outcomes (1)
- measure
- ORR(Objective Response Rate)
- timeFrame
- 2 years
- description
- The proportion of CR(complete response) and PR(partial response) in all patients.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.