Clinical trial NCT04516616: Pd-1 Antibody Combined Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer
Official title: Study of Pd-1 Antibody in Combination with Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Uterine Cervical Neoplasm
Uterine Cervical Cancer
Cervical Cancer
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Women's Hospital School Of Medicine Zhejiang University
name: Qilu Hospital of Shandong University
name: Obstetrics & Gynecology Hospital of Fudan University
name: First Affiliated Hospital of Chongqing Medical University
name: Army Medical University, China
name: Peking University People's Hospital
name: Tianjin Medical University General Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: Chongqing University Cancer Hospital
name: The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
First posted: 2020-08-18
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Subjects will receive therapy Q3W until evaluation of efficacy. The first cycle include cisplatin and albumin-bound paclitaxel. A combination of anti-PD-1 antibody (SHR-1210) with cisplatin and albumin-bound paclitaxel would be given in second and third cycles. Patients who have demonstrated complete or partial tumour responses （CR/PR）will receive surgery and receive postoperative adjuvant therapy in accordance with NCCN guideline. Patients who have demonstrated stable disease or progressive disease （SD/PD）will receive concurrent radiochemotherapy.

Eligibility criteria: 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 outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 3 months
Secondary outcomes:
measure: Pathological response rate
timeFrame: 3 months
measure: Event-free survival (EFS)
timeFrame: 5 years
measure: Overall survival （OS）
timeFrame: 5 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital, Tongji Medical College, HUST
name: Ding Ma, M.D., PhD
role: STUDY_CHAIR
References: