Combination Therapy for First Line Treatment of Advanced Cervical Cancer

Advanced Cervical Cancer Clinical Trial

Official title:

Combination of Paclitaxel, Cisplatin\Carboplatin With Toripalimab and Anlotinib for First Line Treatment of Advanced Cervical Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04731038
• Other study ID #: COMSTRAIN-CESC
• Status: Recruiting
• Phase: Phase 1
• Start date: August 1, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: September 2021
• Source: Ruijin Hospital
• Contact: Wenqi Xi
• Phone: +86-13601782226
• Email: xwq11061[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Anlotinib, Toripalimab, Paclitaxel, Cisplatin/ Carboplatin
This is a single-arm study with all patients receiving these four drugs.

Locations

Country	Name	City	State
China	Department of Oncology, Ruijin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: adverse events as assessed by CTCAE v5.0		36 months
Secondary	Progression free survival		36 months
Secondary	Overall survival		36 months
Secondary	Objective response rate		36 months
Secondary	Disease control rate		36 months
Secondary	Duration of response		36 months