Advanced Cervical Cancer
Conditions
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 metastatic 、persistent or recurrent disease after radical surgery、radical platinum-based concurrent chemoradiotherapy or both (Stage IA-IVA).
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 Cisplatin\\Carboplatin, PD-L1 antibody Toripalimab and Anlotinib.
Interventions
DRUGAnlotinib, Toripalimab, Paclitaxel, Cisplatin/ Carboplatin
This is a single-arm study with all patients receiving these four drugs.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. female patients aged≥18 years. 2. Histologically confirmed cervical squamous cell carcinoma or adenocarcinoma, without uncontrolled pleural effusion or ascites. 3. 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. 4. ECOG performance status 0 or 2, expected lifetime≥3 months. 5. 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. 6. HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA\<500IU/ml (or 2500 copies/ml). 7. Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment. 8. 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
1. Pregnancy or children bearing potential. 2. brain or meningeal metastasis. 3. With second primary malignant diseases. 4. With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (\>10mg/d prednisone). 5. With uncontrollable complications 6. Inadequate organ function 7. Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction). 8. known hypersensitivity reaction to any of the study drugs or components. 9. Other unsuitable conditions determined by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: adverse events as assessed by CTCAE v5.0 | 36 months |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival | 36 months |
| Overall survival | 36 months |
| Objective response rate | 36 months |
| Disease control rate | 36 months |
| Duration of response | 36 months |
Countries
China
Contacts
Primary ContactWenqi Xi
Outcome results
None listed