Carrilizumab Combined With White Purple for Squamous Cell Carcinoma of Skin

Last updated: August 6, 2023
Sponsor: Henan Cancer Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Lung Cancer

Treatment

Carrilizumab with albumin-binding paclitaxel

Clinical Study ID

NCT05886140
HN-SHR-1210-cSCC-002
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Patients ≥18 years old; ECOG score 0~1, organ function is good; Histologically confirmedfirst-line treatment for locally advanced or relapsed metastatic squamous cell carcinoma ofthe skin. There were measurable tumor lesions evaluated by MRI or CT during the 21 days prior toenrollment; 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 ≥3weeks, and the interval between local radiotherapy was ≥2 weeks;
  2. The interval between previous chemotherapy, targeted therapy, biotherapy, endocrinetherapy 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); Forfemale patients who are not menopausal or have not been surgically sterilized: consentto abstinence from sex or use of effective contraceptive methods during treatment andfor at least 7 months after the last dose in the study treatment; The patientsvoluntarily participated in this study and signed the informed consent. Who can be included as judged by the researcher.

Exclusion

Exclusion Criteria: Previously received anti-PD-1, anti-PD-L1, anti-PD-L2 drug therapy; Also receivingantitumor therapy in other clinical trials; Had major surgical operations within 4 weeksprior to enrollment, or had not fully recovered from such operations; Serious heart diseaseor 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 anyinvestigational drug component in the chemotherapy regimen are not recommended forinclusion. Pregnant and lactating women, fertile women who tested positive for baseline pregnancytests, or patients of childbearing age who did not want to take effective contraceptivemeasures during the entire trial period and within 6 months after the last study; Thoseconsidered unsuitable for inclusion by researchers.

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Carrilizumab with albumin-binding paclitaxel
Phase:
Study Start date:
June 08, 2023
Estimated Completion Date:
April 30, 2025

Study 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.

Connect with a study center

  • Henan Cancer Hospital

    Zhengzhou, Henan 450008
    China

    Active - Recruiting

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