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

NCT04516616Active, Not RecruitingPHASE2INTERVENTIONAL

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.

Key Facts

Lead Sponsor

Huazhong University of Science and Technology

Enrollment

Start Date

2020-12-01

Completion Date

2023-04-30

Study Type

INTERVENTIONAL

Official Title

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

Interventions

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

Conditions

Uterine Cervical NeoplasmUterine Cervical CancerCervical Cancer

Eligibility

Age Range

18 Years – 70 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 3 months

Event-free survival (EFS)

EFS defined as the time interval from the date of participation to disease progression, local or distant recurrence (in patients undergoing surgery), or death due to any cause.

Time frame: 5 years

Overall survival （OS）

OS is defined as the time from the date of participation until death.

Time frame: 5 years

Locations

Tongji Hospital, Wuhan, China