Carrilizumab Combined With White Purple for Squamous Cell Carcinoma of Skin

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

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.

Study Overview

• Status: Recruiting
• Conditions: Squamous Cell Carcinoma of the Skin
• Intervention / Treatment: Drug: Carrilizumab with albumin-binding paclitaxel

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Peng Zhang, Dr; Phone Number: 13526693125; Email: zdzp@zzu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carrilizumab with albumin-binding paclitaxel; All enrolled patients received carrilizumab combined with albumin-binding paclitaxel.	Drug: Carrilizumab with albumin-binding paclitaxel; All enrolled patients received carrilizumab combined with albumin-binding paclitaxel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	The proportion of tumor volume reduction that reaches the predetermined value and maintains the minimum time limit.	It is estimated to take about 60 months from the start of enrollment to the end of the experiment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free-Surviva	The time from the start of treatment to the appearance of secondary growth	The estimated time from enrollment to disease progression is about 24 months.

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: May 14, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 6, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: HN-SHR-1210-cSCC-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No