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Trial Title:
Carrilizumab Combined With White Purple for Squamous Cell Carcinoma of Skin
NCT ID:
NCT05886140
Condition:
Squamous Cell Carcinoma of the Skin
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Paclitaxel
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Carrilizumab with albumin-binding paclitaxel
Description:
All enrolled patients received carrilizumab combined with albumin-binding paclitaxel.
Arm group label:
Carrilizumab with albumin-binding paclitaxel
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Recruiting
Contact:
Last name:
Peng Zhang, Dr
Phone:
13526693125
Email:
zdzp@zzu.edu.cn
Start date:
June 8, 2023
Completion date:
April 30, 2025
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05886140
