Actively Recruiting
Induction Immunotherapy Combined With Chemotherapy Followed by Concurrent Chemoradiotherap and Immunotherapy for Cervical Cancer
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-07-30
34
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To explore the efficacy and tolerability of a platinum-based regimen combined with the PD-1 antibody toripalimab administered prior to concurrent chemoradiotherapy in patients with locally advanced cervical cancer.
CONDITIONS
Official Title
Induction Immunotherapy Combined With Chemotherapy Followed by Concurrent Chemoradiotherap and Immunotherapy for Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 75 years
- Histologically confirmed, untreated locally advanced cervical cancer of squamous, adenocarcinoma, or adenosquamous type
- At least one measurable lesion not previously treated locally
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Estimated life expectancy of 6 months or more
- Eligible for concurrent chemoradiotherapy as assessed by investigator
- No clinically significant active bleeding
- Laboratory values: white blood cells > 4 x 10^9/L; platelets > 100 x 10^9/L
- No history of other malignancies
- Negative pregnancy test and use of effective contraception if of child-bearing potential
- Provided written informed consent before any study procedures
You will not qualify if you...
- Tumor recurrence or distant metastasis at screening
- Active autoimmune disease requiring systemic therapy or chronic high-dose corticosteroids
- Use of systemic corticosteroids or immunosuppressive drugs within 14 days before first study dose or planned during study
- Live-attenuated vaccination within 30 days before first dose or planned during study
- Prior organ transplantation or known HIV infection
- Active hepatitis B or C infection
- Prior therapy with agents targeting PD-1, PD-L1, PD-L2, CD137, CTLA-4, or similar immune checkpoint modulators
- Known allergy to monoclonal antibodies or investigational product components
- History of other malignancies within 5 years except certain treated local cancers
- Severe non-surgical comorbidities or acute infections
- Peripheral neuropathy above Grade 1
- Inadequate blood counts or organ function as specified
- Symptomatic brain metastases
- Serious cardiac conditions
- Severe bone marrow failure
- Uncontrolled psychiatric illness
- Pregnant or breastfeeding women
- Investigator-determined unsuitability
- Concurrent participation in another interventional clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute&Hospital
Tianjin, China
Actively Recruiting
Research Team
J
Jie Chen
CONTACT
Y
Yuanjie Cao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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