NCT06093438 Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer
| NCT ID | NCT06093438 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2025-11-01 |
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 2023-11-01 with a primary completion date of 2025-11-01.
⚠ 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 efficacy of incorporating neoadjuvant immunotherapy into neoadjuvant chemotherapy in locally advanced cervical cancer patients with high risk of recurrence.
Eligibility Criteria
Inclusion Criteria: 1. Untreated locally advanced cervical cancer patients with clear pathological diagnosis 2. 2019 FIGO stage IIIB-IVA. For patients with stage IIIC disease, the short diameter of their metastatic lymph nodes should ≥1.5cm 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 4. Life expectancy \> 6 months 5. Able to tolerate concurrent chemoradiotherapy assessed by researches 6. No obvious active bleeding; 7. Adequate hematological, renal and hepatic functions: 8. No concomitant malignancies 9. Female subjects of childbearing potential should have a negative pregnancy test and must take effective and reliable contraceptive measures during the clinical trial period; 10. Voluntarily-signed informed consent. Exclusion Criteria: 1. Concomitant other malignancies; 2. Patients with metastatic or recurrent disease; 3. Patients received any form of treatment before enrollment; 4. Severe concomitant chronic diseases (diabetes, hypertension, etc.) or acute infections; 5. Impaired hematological, renal or hepatic functions: 1. Hemoglobin \< 9.0 g/dl 2. Neutrophils \< 2000 cells/μl; Leukocytes \< 4 × 109/L 3. Platelets \> 100 × 109/L 4. Serum ALT/AST \> 2.5×UNL 5. Serum Total bilirubin \> 1.5× UNL g. Serum urea nitrogen (BUN) \> 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) \> 1.5 × upper normal limit (UNL) 6. Patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency or severe heart valve disease; 7. Patients with uncontrolled mental diseases; 8. Pregnant or lactating woman; 9. Participating in other clinical trials; 10. Anyone considered not suitable for enrollment by principal investigator;
Contact & Investigator
Jie Chen
PRINCIPAL INVESTIGATOR
Tianjin Medical University Cancer Institute and Hospital
Frequently Asked Questions
Who can join the NCT06093438 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Cervical Cancer. 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 NCT06093438 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 NCT06093438 currently recruiting?
Yes, NCT06093438 is actively recruiting participants. Contact the research team at cyjro325@gmail.com for enrollment information.
Where is the NCT06093438 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06093438 clinical trial?
NCT06093438 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The principal investigator is Jie Chen at Tianjin Medical University Cancer Institute and Hospital. The trial plans to enroll 20 participants.
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