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Carrilizumab Combined With White Purple for Squamous Cell Carcinoma of Skin

Primary Purpose

Squamous Cell Carcinoma of the Skin

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Carrilizumab with albumin-binding paclitaxel
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of the Skin

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients ≥18 years old; ECOG score 0~1, organ function is good; Histologically confirmed first-line treatment for locally advanced or relapsed metastatic squamous cell carcinoma of the skin. There were measurable tumor lesions evaluated by MRI or CT during the 21 days prior to enrollment; If you have received antitumor therapy, the following conditions should be met: The interval between systemic radiotherapy and the first dose in this study was ≥3 weeks, and the interval between local radiotherapy was ≥2 weeks; The interval between previous chemotherapy, targeted therapy, biotherapy, endocrine therapy and other antitumor therapies and the first administration in this study was ≥4 weeks; Normal function of major organs (within 14 days prior to treatment); For female patients who are not menopausal or have not been surgically sterilized: consent to abstinence from sex or use of effective contraceptive methods during treatment and for at least 7 months after the last dose in the study treatment; The patients voluntarily participated in this study and signed the informed consent. Who can be included as judged by the researcher. Exclusion Criteria: Previously received anti-PD-1, anti-PD-L1, anti-PD-L2 drug therapy; Also receiving antitumor therapy in other clinical trials; Had major surgical operations within 4 weeks prior to enrollment, or had not fully recovered from such operations; Serious heart disease or discomfort or concomitant disease that, according to the judgment of the investigator, seriously endangers the safety of the patient or affects the completion of the study; Allergic reactions: Patients who are allergic to the investigational drug or to any investigational drug component in the chemotherapy regimen are not recommended for inclusion. Pregnant and lactating women, fertile women who tested positive for baseline pregnancy tests, or patients of childbearing age who did not want to take effective contraceptive measures during the entire trial period and within 6 months after the last study; Those considered unsuitable for inclusion by researchers.

Sites / Locations

  • Henan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carrilizumab with albumin-binding paclitaxel

Arm Description

All enrolled patients received carrilizumab combined with albumin-binding paclitaxel.

Outcomes

Primary Outcome Measures

Objective Response Rate
The proportion of tumor volume reduction that reaches the predetermined value and maintains the minimum time limit.

Secondary Outcome Measures

Progression-Free-Surviva
The time from the start of treatment to the appearance of secondary growth

Full Information

First Posted
May 14, 2023
Last Updated
August 6, 2023
Sponsor
Henan Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05886140
Brief Title
Carrilizumab Combined With White Purple for Squamous Cell Carcinoma of Skin
Official Title
Carrellizumab Combined With Albumin-binding Paclitaxel in the Treatment of Locally Late Stage or Relapsed Metastatic Cutaneous Squamous Cell Carcinoma: a Single-arm, Open, Multicenter, Prospective Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2023 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study intends to conduct a single-arm, prospective and open clinical study, using carrellizumab combined with albumin-binding paclitaxel regimen for first-line treatment of squamous cell carcinoma of the skin, including 24 patients with squamous cell carcinoma of the skin, to further confirm the efficacy and safety of Carrellizumab combined with albumin-binding paclitaxel in the treatment of squamous cell carcinoma of the skin.
Detailed Description
This study intends to conduct a single-arm, prospective and open clinical study in the Department of Bone and Soft Tissue of Henan Cancer Hospital. The first-line treatment of squamous cell carcinoma of the skin with carrellizumab combined with albumin-binding paclitaxel regimen is adopted. 24 patients with squamous cell carcinoma of the skin are included. It is intended to further confirm the efficacy and safety of carrellizumab combined with albumin-binding paclitaxel in the treatment of cutaneous squamous cell carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carrilizumab with albumin-binding paclitaxel
Arm Type
Experimental
Arm Description
All enrolled patients received carrilizumab combined with albumin-binding paclitaxel.
Intervention Type
Drug
Intervention Name(s)
Carrilizumab with albumin-binding paclitaxel
Intervention Description
All enrolled patients received carrilizumab combined with albumin-binding paclitaxel.
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
The proportion of tumor volume reduction that reaches the predetermined value and maintains the minimum time limit.
Time Frame
It is estimated to take about 60 months from the start of enrollment to the end of the experiment.
Secondary Outcome Measure Information:
Title
Progression-Free-Surviva
Description
The time from the start of treatment to the appearance of secondary growth
Time Frame
The estimated time from enrollment to disease progression is about 24 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients ≥18 years old; ECOG score 0~1, organ function is good; Histologically confirmed first-line treatment for locally advanced or relapsed metastatic squamous cell carcinoma of the skin. There were measurable tumor lesions evaluated by MRI or CT during the 21 days prior to enrollment; If you have received antitumor therapy, the following conditions should be met: The interval between systemic radiotherapy and the first dose in this study was ≥3 weeks, and the interval between local radiotherapy was ≥2 weeks; The interval between previous chemotherapy, targeted therapy, biotherapy, endocrine therapy and other antitumor therapies and the first administration in this study was ≥4 weeks; Normal function of major organs (within 14 days prior to treatment); For female patients who are not menopausal or have not been surgically sterilized: consent to abstinence from sex or use of effective contraceptive methods during treatment and for at least 7 months after the last dose in the study treatment; The patients voluntarily participated in this study and signed the informed consent. Who can be included as judged by the researcher. Exclusion Criteria: Previously received anti-PD-1, anti-PD-L1, anti-PD-L2 drug therapy; Also receiving antitumor therapy in other clinical trials; Had major surgical operations within 4 weeks prior to enrollment, or had not fully recovered from such operations; Serious heart disease or discomfort or concomitant disease that, according to the judgment of the investigator, seriously endangers the safety of the patient or affects the completion of the study; Allergic reactions: Patients who are allergic to the investigational drug or to any investigational drug component in the chemotherapy regimen are not recommended for inclusion. Pregnant and lactating women, fertile women who tested positive for baseline pregnancy tests, or patients of childbearing age who did not want to take effective contraceptive measures during the entire trial period and within 6 months after the last study; Those considered unsuitable for inclusion by researchers.
Facility Information:
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Zhang, Dr
Phone
13526693125
Email
zdzp@zzu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Carrilizumab Combined With White Purple for Squamous Cell Carcinoma of Skin

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