NCT04516616Active, not recruitingPhase 2
Pd-1 Antibody Combined Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer
Study of Pd-1 Antibody in Combination with Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer
Source: ClinicalTrials.gov · Last updated 20 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 85 (actual)
- First submitted
- 13 Aug 2020
- Start date
- 1 Dec 2020
- Primary completion date
- 30 Apr 2023
- Lead sponsor
- Huazhong University of Science and Technology
- Diseases
- Cervical cancer
- NCT number
- NCT04516616
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 85
- From 1 Dec 2020 to the primary completion date, 30 Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Condition requiring systemic treatment with small doses of corticosteroids within 1 months or large doses of corticosteroids within 3 months prior to randomization.
- Participate in other drug clinical trials at the same time.
- Drug or alcohol abuse.
Other illness
- 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.
- HIV infection, active HBV/HCV.
- Any primary malignancy within 5 years.
- 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.
Other
- Pregnant or lactating female patients.
- Unable or unwilling to sign informed consents.
- Not eligible for the study judged by researchers.
Who the study is looking for
- Patients with locally advanced (2018 FIGO staged IB3, IIA2 and IIB/IIIC1r（tumor size ≥ 4cm) ) cervical cancer and had not received any treatment before.
- Histologically confirmed squamous carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix.
- Pathological examination of the PD-L1 positive（Combined score Positive Score≥1）.
- Females 18-70 years of age.
- Eastern Cooperative Oncology Group score 0-1.
- 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.
- Well-compliance and willing to keep in touch.
- Willing to participate in this study, and sign the informed consent.
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.