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Efficacy and safety of TP regimen combined with PD-1 monoclonal antibody as neoadjuvant therapy for locally advanced cervical cancer

Efficacy and safety of TP regimen combined with PD-1 monoclonal antibody as neoadjuvant therapy for locally advanced cervical cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064398
Enrollment
Unknown
Registered
2022-10-06
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical carcinoma

Interventions

treatment group:Zimberelimab

Sponsors

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Postmenopausal women with sexual history; 2. The pathological diagnosis of biopsy tissue of cervical lesions was cervical squamous cell carcinoma, and the FIGO staging was IB3-IIA2; 3. Have not received any treatment related to cervical cancer before treatment; 4. Before treatment, PETCT or MRI showed tumor volume>5.0 cm; 5. The number of white blood cells and platelets are within the normal range, the total bilirubin, AST, ALT are less than 1.5 times the upper limit of the normal value, and the serum creatinine and serum urea nitrogen are within the normal range; 6. Highly cooperative, willing to participate in the project and signed the informed consent form manually.

Exclusion criteria

Exclusion criteria: 1. Diagnosis that does not conform to this item; 2. Pregnant or lactating women; 3. Patients with active or suspected autoimmune diseases need systematic treatment; 4. People living with HIV; 5. Those who have used corticosteroids 3 months before treatment or need to use large doses of corticosteroids for systemic treatment during treatment; 6. Cardiac insufficiency (NYHA grade III-IV), developmental malformation of liver and kidney or history of surgery, nervous system disorder or lack of autonomic activity; 7. Alcohol or drug abusers; 8. Those who are unable or unwilling to cooperate actively.

Design outcomes

Primary

MeasureTime frame
pathologic complete remission, PCR;Major pathologic response rates, MPR;

Countries

China

Contacts

Public ContactGuiling LI, Shouhua Yang

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

lgl6714@163.com+86 13307187507/+86 13971620149

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026