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Clinical Trials in China / NCT04516616
Active, not recruiting Phase 2

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

NCT04516616 · tracked via the Priya Life Science China tracker
Sponsor
Huazhong University of Science and Technology
Phase
Phase 2
Started
2020-12-01
Last updated
2025-03-20

Condition(s) studied

Uterine Cervical NeoplasmUterine Cervical CancerCervical Cancer

Investigational drug(s) / intervention(s)

Cisplatin+Albumin-bound paclitaxel (1 cycle) and PD-1 monoclonal antibody+Cisplatin+Albumin-bound paclitaxel (2 cycles)

Cisplatin+Albumin-bound paclitaxel (1 cycle) and PD-1 monoclonal antibody+Cisplatin+Albumin-bound paclitaxel (2 cycles): PD-1 monoclonal antibody (SHR-1210):200mg,IV infusion,Q3W Cisplatin:75-80 mg/m2, IV infusion, Q3W Albumin-bound paclitaxel: 260 mg/m2,30min,IV infusion, Q3W

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients with locally advanced (2018 FIGO staged IB3, IIA2 and IIB/IIIC1r(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 18-70 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tongji Hospital Wuhan Hubei

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04516616 on ClinicalTrials.gov ↗ ← All trials in China