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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
85
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
Tongji Hospital
Wuhan, Hubei, China
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
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
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