A Study of SHR-1701 Plus Platinum-containing Chemotherapy With or Without BP102 (Bevacizumab) as First-line Treatment in Cervical Cancer

  • STATUS
    Recruiting
  • End date
    May 24, 2025
  • participants needed
    572
  • sponsor
    Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Updated on 24 April 2022
paclitaxel
measurable disease
carcinoma
squamous cell carcinoma
carboplatin
bevacizumab
adenocarcinoma
metastatic cervical cancer

Summary

The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer.

Details
Condition Cervical Cancer
Treatment SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102, SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102, Placebo + paclitaxel + cisplatin/carboplatin ± BP102
Clinical Study IdentifierNCT05179239
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.
Last Modified on24 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 18-70 years, female
With Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1
With a life expectancy of ≥ 12 weeks
Acute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0)
With at least one measurable lesion as per RECIST v1.1
With histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix
Persistent, recurrent, or metastatic cervical cancer
Patients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred)
Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment
Patients must agree and have signed the informed consent form

Exclusion Criteria

With known contraindications to paclitaxel, cisplatin, or carboplatin
With known allergies to any of the study drugs or their excipients; severe allergic reactions to other monoclonal antibodies
With inadequately treated CNS metastasis
With uncontrolled hypertension
With uncontrolled cardiac diseases or symptoms
With major vascular disease
With arterial/venous thrombotic events within 6 months prior to randomization
Have received full-dose anticoagulant or hemolytic therapy within 10 days prior to randomization
With clinically significant hemorrhage or definitive bleeding diathesis within 3 months prior to randomization
With severe, unhealed, or open wounds as well as active ulcers or untreated fractures
With any active autoimmune disease or a history of autoimmune disease that is expected to recur
Had other active malignant tumors within 5 years prior to study enrolment
With congenital or acquired immunodeficiency (such as HIV-infected patients)
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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