Combination Therapy for First Line Treatment of Advanced Cervical Cancer

Phase 1

• Conditions: Advanced Cervical Cancer
• Interventions: Drug: Anlotinib, Toripalimab, Paclitaxel, Cisplatin/ Carboplatin

• Registration Number: NCT04731038
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-01-27
• Study First Posted: 2021-01-29
• Study Start: 2021-08-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-17
• Primary Completion: 2022-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Anlotinib, Toripalimab, Paclitaxel, Cisplatin/ Carboplatin	Anlotinib 12mg qd. po. d1-d14 q3w Toripalimab 240mg ivgtt. d1 q3w Paclitaxel 135mg/m2 ivgtt. d1 q3w Cisplatin 50mg/m2 ivgtt. d1 q3w Carboplatin AUC=5 ivgtt. d1 q3w

Primary Outcome Measures

Name	Time	Method
Safety: adverse events as assessed by CTCAE v5.0	36 months

Secondary Outcome Measures

Name	Time	Method
Progression free survival	36 months
Overall survival	36 months
Objective response rate	36 months
Duration of response	36 months
Disease control rate	36 months

Trial Locations

Locations (1)

Department of Oncology, Ruijin Hospital; 🇨🇳 Shanghai, China