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NCT Number: NCT04188860

Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy

For recurrent or persistent advanced cervical cancer patients, the first-line chemotherapy was based on platinum. However, if they were refractory to platinum-based chemotherapy, there were no other more effective medications or treatment. The marketing of anti-PD-1 antibody has provided an opportunity of curative management. This single arm, open, phase II trial would recruit 34 eligible patients. A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for first 9 patients. If at least total 2 patients achieved complete or partial remission, or at least total 6 patients achieved complete or partial remission or stable disease, the same regimen would be given for rest patients. The primary end is overall response rate (ORR). The second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. A molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.

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Key information

Conditions

Recurrent Cervical Carcinoma Anti-PD-1 Antibody Chemotherapy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Immunotherapy Neoplasms Neoplasms by Site Persistent Advanced Cervical Carcinoma Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Lei Li

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female of 18-75 years old
  • Eastern Cooperative Oncology Group score 0-1
  • Pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma, with stage IA1 (with lymph-vascular space invasion) to IVB, which had accepted radical treatment for the purpose of cure
  • Having accepted at least one regimen of platinum-based chemotherapy after the diagnosis of recurrent or persistent advanced cervical cancer, and having an interval of at least 4 weeks since fulfilling the last treatment regimen
  • At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1
  • Anticipative survival period of 3 months or more
  • Lab testing within reference ranges
  • With appropriate contraception
  • Provided consents of participating the trial

Exclusion criteria

  • With brain metastasis
  • With addiction to psychiatric medications or with mental disorders
  • With following history and/or complications: autoimmune disease; systematic utilization of corticosteroids (with equivalent of prednison of > 10 mg/day) or other immunosuppressors within 14 days; utilization of antitumor vaccine or other immunostimulation treatment with 3 months; exposure to PD-1 antibody, or PD-L1 antibody, or PD-L2 antibody, or cytotoxic T lymphocyte-associated antigen-4 antibody; history of other malignancies; pulmonary tuberculosis; interstitial pneumonia or related history; active hepatitis; positive testing of human immunodeficiency
  • With adverse effects more than Common Terminology Criteria for Adverse Events grade 1 (except for alopecia), which caused by previous anti-tumor treatment
  • With infective disease which need systematic treatment within 14 days
  • With severe open trauma, fracture or major surgery with past 4 weeks
  • With potential allergy or intolerance to study regimens
  • Not eligible for the study judged by researchers

Treatment and study plan

A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel

Drug

A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for all patients:

  • Camrelizumab: 200 mg every time, every 3 weeks, which would be sustained until the appearance of disease progression on intolerable adverse events, and no more than 24 months
  • Albumin-bound paclitaxel: 200-300 mg every time, every 3 weeks, no more than 6 courses

Primary outcomes

  1. Overall response rate

    Time frame: One year

    The rates of complete and partial remission

Secondary outcomes

  1. Progression-free survival

    Time frame: One year

    The length of time during and after the treatment of the cancer, that a patient lives with the disease but it does not get worse

  2. Overall survival

    Time frame: One year

    The length of time from either the date of diagnosis or the start of treatment for the cancer, that patients diagnosed with the disease are still alive.

  3. Disease control rate

    Time frame: One year

    The rates of complete and partial remission, and stable disease

  4. Remission duration

    Time frame: One years

    The duration of complete and partial remission

  5. Adverse event rates

    Time frame: One year

    The rates of adverse events judged by Common Terminology Criteria for Adverse Events

Sponsors and collaborators

Lead sponsor

Lei Li

Other

Registry information

Official study title

Anti-PD-1 Antibody Camrelizumab Combined With Albumin-bound Paclitaxel for Recurrent and Persistent Advanced Cervical Cancer Refractory to Platinum-based Chemotherapy: A Single Arm, Single Center, Open, Phase II Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 6, 2019
Registry last updated
Mar 15, 2022

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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