Combination Therapy for First Line Treatment of Advanced... | NCT04731038

Studies
Combination Therapy for First Line Treatment of Advanced Cervical Cancer

NCT04731038

Sponsor

Ruijin Hospital

Status

Unknown status

Last Update Posted

Sep 17, 2021Actual

Enrollment

20Estimated

Phase

Phase 1

Conditions

Advanced Cervical Cancer

Interventions

Anlotinib, Toripalimab, Paclitaxel, Cisplatin/ Carboplatin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2021Actual

Primary Completion Date

Jul 1, 2022Estimated

Completion Date

Jul 1, 2024Estimated

First Submitted Date

Jan 27, 2021

First Submission Date that Met QC Criteria

Jan 27, 2021

First Posted Date

Jan 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2021

Last Update Posted Date

Sep 17, 2021Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	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	Drug: Anlotinib, Toripalimab, Paclitaxel, Cisplatin/ Carboplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anlotinib, Toripalimab, Paclitaxel, Cisplatin/ Carboplatin	Drug	This is a single-arm study with all patients receiving these four drugs.	Experimental

Measure	Description	Time Frame
Safety: adverse events as assessed by CTCAE v5.0		36 months

Measure	Description	Time Frame
Progression free survival		36 months
Overall survival		36 months
Objective response rate

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
C000625192	anlotinib
C000656314	toripalimab
D017239	Paclitaxel
D002945	Cisplatin
D016190	Carboplatin

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic