Status:
UNKNOWN
Combination Therapy for First Line Treatment of Advanced Cervical Cancer
Lead Sponsor:
Ruijin Hospital
Conditions:
Advanced Cervical Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
Advanced cervical cancer patients with metastatic, persistent or recurrent disease after radical surgery、radical platinum-based concurrent chemoradiotherapy or both will be treated by Paclitaxel plus ...
Eligibility Criteria
Inclusion
- female patients aged≥18 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 surgery、radical platinum-based concurrent chemoradiotherapy or both （Stage IA-IVA）, with measurable lesions.
- ECOG performance status 0 or 2, expected lifetime≥3 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
- 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.
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04731038
Start Date
August 1 2021
End Date
July 1 2024
Last Update
September 17 2021
Active Locations (1)
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1
Department of Oncology, Ruijin Hospital
Shanghai, China, 200025