Actively Recruiting
Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer Patients With High Risk of Recurrence: A Prospective, Single-Arm, Phase II Trial
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-03-11
20
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of neoadjuvant immunotherapy combined with chemotherapy in patients with locally advanced cervical cancer who have a high risk of recurrence. The study aims to reduce the risk of distant metastasis, which is a major concern for these patients undergoing chemoradiotherapy, and to improve disease-free survival. This is a prospective, single-arm, phase II trial conducted by Tianjin Medical University Cancer Institute and Hospital. Participants will receive three cycles of induction treatment consisting of Toripalimab, paclitaxel, and cisplatin, with or without bevacizumab, before definitive chemoradiotherapy. After induction, pelvic MRI will assess tumor regression. Those with satisfactory response will proceed to chemoradiotherapy with weekly cisplatin and Toripalimab every three weeks. Following chemoradiotherapy, patients will receive another three cycles of consolidation treatment identical to the induction regimen. During the study, patients will undergo regular evaluations including MRI scans to monitor tumor response and treatment effects. Researchers will track outcomes such as overall response rate at one year and changes in tumor and normal tissue volumes over five years. Secondary outcomes include progression-free survival, distant metastasis-free survival, and treatment-related side effects monitored up to five years. Participants will be followed closely throughout treatment and during long-term observation to assess safety and effectiveness.
CONDITIONS
Brief Title
Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Untreated locally advanced cervical cancer patients with clear pathological diagnosis
- 2019 FIGO stage IIIB-IVA, or stage IIIC with metastatic lymph nodes 651.5 cm in short diameter
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Life expectancy greater than 6 months
- Able to tolerate concurrent chemoradiotherapy as assessed by researchers
- No obvious active bleeding
- Adequate hematological, renal, and hepatic functions
- No concomitant malignancies
- Female subjects of childbearing potential must have a negative pregnancy test and use effective contraception during the trial
- Voluntarily-signed informed consent
You will not qualify if you...
- Presence of other malignancies
- Metastatic or recurrent disease
- Prior treatment for cervical cancer
- Severe chronic diseases such as diabetes or hypertension, or acute infections
- Impaired hematological, renal, or hepatic functions including:
- Hemoglobin less than 9.0 g/dl
- Neutrophils less than 2000 cells/bcL; Leukocytes less than 4 �d7 10^9/L
- Platelets greater than 100 �d7 10^9/L
- Serum ALT/AST greater than 2.5 times the upper normal limit
- Serum total bilirubin greater than 1.5 times the upper normal limit
- Serum urea nitrogen greater than 1.5 times the upper normal limit
- Serum creatinine greater than 1.5 times the upper normal limit
- Significant heart conditions such as arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, or severe valve disease
- Uncontrolled mental illnesses
- Pregnancy or breastfeeding
- Participation in other clinical trials
- Any other condition considered unsuitable by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 weeks
Participants receive three cycles of induction immunotherapy and chemotherapy followed by definitive chemoradiotherapy with concurrent weekly cisplatin and toripalimab every three weeks, and then three cycles of consolidated immunotherapy and chemotherapy.
Weekly visits during chemoradiotherapy and 3 visits for induction treatment plus 3 visits for consolidated treatment
Duration - Up to 5 years
Participants are monitored for treatment response, disease progression, and side effects following completion of therapy.
Visits scheduled according to study follow-up protocol
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
Y
Yuanjie Cao
C
Chen Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here