Carrilizumab Combined With White Purple for Squamous Cell Carcinoma of Skin

NCT05886140 | Unknown DMC

• 1 other identifier: HN-SHR-1210-cSCC-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Carcinoma of the Skin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Progression-Free-Surviva

  The estimated time from enrollment to disease progression is about 24 months.

Study Arms (1)

Carrilizumab with albumin-binding paclitaxel

EXPERIMENTAL

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

Drug: Carrilizumab with albumin-binding paclitaxel

Interventions

Carrilizumab with albumin-binding paclitaxel DRUG

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

Carrilizumab with albumin-binding paclitaxel

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: June 2, 2023
• Study Start: June 8, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: August 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)