Pd-1 Antibody Combined Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer

• Status: Recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

Cervical cancer is one of the major health problems for chinese women. Besides surgery and radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many studies. However, not all patients respond well to neoadjuvant chemotherapy. This is an open-label, single-arm, multi-center clinical trial to evaluate whether PD-1 in combination with neoadjuvant chemotherapy will achieve better objective response rate.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huazhong University of Science and Technology
• Collaborators: Army Medical University; Chongqing University Cancer Hospital; First Affiliated Hospital of Chongqing Medical University; Harbin Medical University; Obstetrics & Gynecology Hospital of Fudan University; Peking University People's Hospital; Qilu Hospital of Shandong University; Tianjin Medical University General Hospital; Women's Hospital School Of Medicine Zhejiang University
• Treatments: Albumin-Bound Paclitaxel; Antibodies; Antibodies, Monoclonal; Cisplatin; Paclitaxel

Criteria

Inclusion Criteria:

1. Patients with locally advanced (2019 FIGO staged IB3, IIA2 and IIB（tumor size> 4cm) ) cervical cancer and had not received any treatment before.

2. Histologically confirmed squamous carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix.

3. Pathological examination of the PD-L1 positive（Combined score Positive Score≥1）.

4. Females 18-65 years of age.

5. Eastern Cooperative Oncology Group score 0-1.

6. WBC≥3.5*10^9/L, NEU≥1.5*10^9/L, Platelet≥80×10^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value.

7. Well-compliance and willing to keep in touch.

8. Willing to participate in this study, and sign the informed consent.

Exclusion Criteria:

1. Active or known or suspected autoimmune disease requires a system treatment as follows but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring intervention with bronchodilators.

2. HIV infection, active HBV/HCV.

3. Condition requiring systemic treatment with small doses of corticosteroids within 1 months or large doses of corticosteroids within 3 months prior to randomization.

4. Any primary malignancy within 5 years.

5. Participate in other drug clinical trials at the same time.

6. Pregnant or lactating female patients.

7. Comorbidity including but not limited to: heart diseases (grade III-IV cardiac insufficiency (NYHA standard); central nervous system diseases or nonfunctional behavior; hematological system diseases; liver or kidney malformation or history of surgery.

8. Drug or alcohol abuse.

9. Unable or unwilling to sign informed consents.

10. Not eligible for the study judged by researchers.