Combination Therapy for First Line Treatment of Advanced Cervical Cancer

  • STATUS
    Recruiting
  • End date
    Jul 1, 2024
  • participants needed
    20
  • sponsor
    Ruijin Hospital
Updated on 24 September 2021

Summary

This is a single center phase 1 trail to observe safety and efficacy of Paclitaxel plus Cisplatin\Carboplatin, PD-L1 antibody Toripalimab and Anlotinib as first-line regimen to treat the patient with metastatic persistent or recurrent disease after radical surgeryradical platinum-based concurrent chemoradiotherapy or both (Stage IA-IVA).

Description

Advanced cervical cancer patients with metastatic, persistent or recurrent disease after radical surgeryradical platinum-based concurrent chemoradiotherapy or both will be treated by Paclitaxel plus Cisplatin\Carboplatin, PD-L1 antibody Toripalimab and Anlotinib.

Details
Condition Advanced Cervical Cancer
Treatment Anlotinib, Toripalimab, Paclitaxel, Cisplatin/ Carboplatin
Clinical Study IdentifierNCT04731038
SponsorRuijin Hospital
Last Modified on24 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

female patients aged18 years
Histologically confirmed cervical squamous cell carcinoma or adenocarcinoma, without uncontrolled pleural effusion or ascites
Patients with advanced or metastatic disease who have disease progression after radical surgeryradical platinum-based concurrent chemoradiotherapy or both Stage IA-IVA, with measurable lesions
ECOG performance status 0 or 2, expected lifetime3 months
Adequate organ function: Absolute neutrophil count (ANC) 1.5x109/L, White blood count 3.5x109/L, Platelets 100x109/L, Hemoglobin (Hb) 100g/L, ALT/AST 2.5x ULN (for patient with liver metastasis ALT/AST 5x ULN), Serum bilirubin 1.5x ULN, Serum creatinine 1.5x ULN
HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA<500IU/ml (or 2500 copies/ml)
Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment
Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form

Exclusion Criteria

Pregnancy or children bearing potential
brain or meningeal metastasis
With second primary malignant diseases
With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (>10mg/d prednisone)
With uncontrollable complications
Inadequate organ function
Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction)
known hypersensitivity reaction to any of the study drugs or components
Other unsuitable conditions determined by investigators
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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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