NCT06391190 Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor in Advanced Cervical Cancer
| NCT ID | NCT06391190 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | RenJi Hospital |
| Condition | Locally Advanced Cervical Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2024-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2022-01-01 with a primary completion date of 2024-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To explore the safety and efficacy of Albumin-Bound Paclitaxel/Platinum based concurrent chemoradiotherapy Followed by PD-1 inhibitor (Sintilimab) in locally advanced cervical cancer
Eligibility Criteria
Inclusion Criteria: 1. Age between 18 and 75; 2. Untreated patients with pathologically proven locally advanced cervical cancer; 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 4. Adequate hematological, renal and hepatic functions: 4.1 Hemoglobin \> 8.0 g/dl 4.2 Neutrophils \> 2000 cells/μl; Leukocytes \> 4 × 109/L 4.3 Platelets \> 100 × 109/Lg. 4.4 Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL) 4.5 Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL) 4.6 Serum ALT/AST ≤ 2.5× UNL 4.7 Serum Total bilirubin ≤ 1.5× UNL 5. Life expectancy \> 6 months 6. Eligible for concurrent chemoradiotherapy assessed by principle investigator; 7. No obvious active bleeding; 8. Written informed consent must be available before study registration. Exclusion Criteria: 1. Recurrent or distant metastatic disease; 2. Prior malignancies (other than curable non-melanoma skin cancer) within 5 years; 3. Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants; 4. Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study; 5. Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study; 6. Previous organ transplantation or HIV patients; 7. Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component; 8. Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA\> 2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA\> 103 copies/ml.
Frequently Asked Questions
Who can join the NCT06391190 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Locally Advanced Cervical Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06391190 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06391190 currently recruiting?
Yes, NCT06391190 is actively recruiting participants. Visit ClinicalTrials.gov or contact RenJi Hospital to inquire about joining.
Where is the NCT06391190 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06391190 clinical trial?
NCT06391190 is sponsored by RenJi Hospital. The trial plans to enroll 20 participants.