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Combination Therapy for First Line Treatment of Advanced Cervical Cancer

Primary Purpose

Advanced Cervical Cancer

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Anlotinib, Toripalimab, Paclitaxel, Cisplatin/ Carboplatin

About this trial

This is an interventional treatment trial for Advanced Cervical Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 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.

Sites / Locations

Department of Oncology, Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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

Outcomes

Primary Outcome Measures

Safety: adverse events as assessed by CTCAE v5.0

Secondary Outcome Measures

Progression free survival

Overall survival

Objective response rate

Disease control rate

Duration of response

Full Information

NCT ID

NCT04731038

First Posted

January 27, 2021

Last Updated

September 16, 2021

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04731038

Brief Title

Combination Therapy for First Line Treatment of Advanced Cervical Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2021 (Actual)

Primary Completion Date

July 1, 2022 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Cervical Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Anlotinib, Toripalimab, Paclitaxel, Cisplatin/ Carboplatin

Intervention Description

This is a single-arm study with all patients receiving these four drugs.

Primary Outcome Measure Information:

Title

Safety: adverse events as assessed by CTCAE v5.0

Time Frame

36 months

Secondary Outcome Measure Information:

Title

Progression free survival

Time Frame

36 months

Title

Overall survival

Time Frame

36 months

Title

Objective response rate

Time Frame

36 months

Title

Disease control rate

Time Frame

36 months

Title

Duration of response

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wenqi Xi

Phone

+86-13601782226

xwq11061@rjh.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Zhang, MD & Ph. D

Organizational Affiliation

Ruijin Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Oncology, Ruijin Hospital

City

Shanghai

ZIP/Postal Code

200025

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Zhang, MD & Ph. D

Phone

+86-13818332497

junzhang10977@sjtu.edu.cn

First Name & Middle Initial & Last Name & Degree

Jun Zhang, MD & Ph. D

12. IPD Sharing Statement

Learn more about this trial

Combination Therapy for First Line Treatment of Advanced Cervical Cancer

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