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

Cervical Cancer Clinical Trial

Official title:

Study of Pd-1 Antibody in Combination With Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04516616
• Other study ID #: 2020-S112
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2020
• Est. completion date: July 1, 2028

Study information

• Verified date: March 2023
• Source: Huazhong University of Science and Technology
• Contact: Ding Ma, M.D., PhD
• Phone: 0086-27-836268
• Email: dma[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: July 1, 2028
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients with locally advanced (2019 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 18-65 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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Cancer
• Uterine Cervical Neoplasm
• Uterine Cervical Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (10)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	ORR is defined as the percentage of the participants in the ITT population who have a Complete Response or Partial Response. The ORR will be assessed by a blind independent central reviewer per RECIST 1.1	3 months
Secondary	Pathological response rate	Pathological response rate is defined as the percentage of the participants in the ITT population who have complete pathologic remission or the infiltration depth of cervical lesions was < 3mm in histological examination.	3 months
Secondary	Event-free survival (EFS)	EFS defined as the time interval from the date of randomization to disease progression, local or distant recurrence (in patients undergoing surgery), or death due to any cause.	5 years
Secondary	Overall survival (OS)	OS is defined as the time from the date of randomization until death.	5 years