NCT05554276 Neoadjuvant Chemotherapy Combined With PD-1 + Radical Radiotherapy in Locally Advanced Cervical Cancer
| NCT ID | NCT05554276 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Jiao Tong University Affiliated Sixth People's Hospital |
| Condition | Neoadjuvant Chemotherapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2025-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 36 participants in total. It began in 2023-08-01 with a primary completion date of 2025-01-31.
⚠ 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
Based on various external factors and differences in the basic characteristics of patients, in my country, it is not clear whether concurrent chemoradiotherapy can achieve optimal therapeutic effect in patients with pathologically diagnosed stage IIB or above locally advanced cervical cancer. Under the limitations of radiotherapy and surgery conditions in the region, some patients will try neoadjuvant chemotherapy combined with PD-1 antibody therapy before standard radiotherapy, hoping to reduce cancer focus and reduce infiltration. Thereby reducing the scope of radiotherapy, better ensure the efficacy of late radiotherapy and chemotherapy and reduce the side effects of radiotherapy. Judging from the review of such patients, neoadjuvant chemotherapy combined with PD-1 antibody therapy + radical radiotherapy seems to have certain efficacy and tolerance in the near future as expected. No statistical analysis has been done on the long-term survival of patients. This topic intends to treat inoperable locally advanced cervical cancer patients with neoadjuvant chemotherapy combined with PD-1 antibody + radical radiotherapy, and explore the treatment-related toxic and side effects and efficacy of neoadjuvant chemotherapy combined with PD-1 antibody + radical radiotherapy. It is hoped that through this study, it will provide a reference for the comprehensive treatment of inoperable locally advanced cervical cancer that has been pathologically diagnosed in the future.
Eligibility Criteria
Inclusion Criteria: * Patients who were pathologically diagnosed with cervical squamous cell carcinoma and were assessed as unresectable. Exclusion Criteria: * Any active or present autoimmune disease (eg, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism)
Contact & Investigator
Jie Fu, Dr
STUDY CHAIR
Shanghai Sixth People's Hospital, Shanghai Jiao Tong University
Frequently Asked Questions
Who can join the NCT05554276 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Neoadjuvant Chemotherapy. 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 NCT05554276 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05554276 currently recruiting?
Yes, NCT05554276 is actively recruiting participants. Contact the research team at fujie74@sjtu.edu.cn for enrollment information.
Where is the NCT05554276 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05554276 clinical trial?
NCT05554276 is sponsored by Shanghai Jiao Tong University Affiliated Sixth People's Hospital. The principal investigator is Jie Fu, Dr at Shanghai Sixth People's Hospital, Shanghai Jiao Tong University. The trial plans to enroll 36 participants.