Carrilizumab Combined With White Purple for Squamous Cell Carcinoma of Skin

NCT ID: NCT05886140

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-08
• Study Completion Date: 2025-04-30

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.

Conditions

Squamous Cell Carcinoma of the Skin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carrilizumab with albumin-binding paclitaxel

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

Group Type: EXPERIMENTAL

Carrilizumab with albumin-binding paclitaxel

Intervention Type: DRUG

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

Interventions

Carrilizumab with albumin-binding paclitaxel

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

Intervention Type: DRUG

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:

1. The interval between systemic radiotherapy and the first dose in this study was ≥3 weeks, and the interval between local radiotherapy was ≥2 weeks;

2. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zhang Peng

Deputy chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Peng Zhang, Dr

Role: primary

zdzp@zzu.edu.cn

13526693125

Other Identifiers

HN-SHR-1210-cSCC-002

Identifier Type: -

Identifier Source: org_study_id