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Active, Not Recruiting

NCT Number: NCT04516616

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Condition requiring systemic treatment with small doses of corticosteroids within 1 months or large doses of corticosteroids within 3 months prior to randomization.
  • Any primary malignancy within 5 years.
  • Participate in other drug clinical trials at the same time.
  • Pregnant or lactating female patients.
  • 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.
  • Drug or alcohol abuse.
  • Unable or unwilling to sign informed consents.
  • Not eligible for the study judged by researchers.

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: 3 months

    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

Secondary outcomes

  1. Pathological response rate

    Time frame: 3 months

    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.

  2. Event-free survival (EFS)

    Time frame: 5 years

    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.

  3. Overall survival (OS)

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Collaborators

  • Army Medical University, China
  • Chongqing University Cancer Hospital
  • First Affiliated Hospital of Chongqing Medical University
  • Obstetrics & Gynecology Hospital of Fudan University
  • Peking University People's Hospital
  • Qilu Hospital of Shandong University
  • The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
  • The Second Affiliated Hospital of Harbin Medical University
  • Tianjin Medical University General Hospital
  • Women's Hospital School Of Medicine Zhejiang University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2028
First posted
Aug 18, 2020
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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