Camrelizumab Combined With Cisplatin in the Treatment of Advanced Cutaneous Squamous Cell Carcinoma

NCT05490485 | Unknown Phase 2 DMC

• 1 other identifier: ZZCSCC-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a card Rayleigh bead single combined cisplatin treatment of advanced squamous cell carcinoma of the skin resistance of single arm phase II study, open, single center, plan in two years into the group of 20 cases with histologic diagnosis of lymph node metastasis or distant metastasis CSCC of (1) or surgery can't/couldn't thorough radiotherapy, CSCC of locally advanced (class 2), To evaluate the efficacy of camrelizumab (PD-1 mab) combined with cisplatin in the treatment of advanced CSCC.

Conditions

Squamous Cell Carcinoma of the Skin

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

  From initiation of treatment to progression of the disease

  Up to approximately 24months

• Overall survival

  Time from the start of treatment to death

  Up to approximately 120months

Study Arms (1)

Camrelizumab

EXPERIMENTAL

Camrelizumab (PD-1 MAB) combined with cisplatin for advanced cutaneous squamous cell carcinoma

Drug: Camrelizumab

Interventions

Camrelizumab DRUG

Camrelizumab combined with cisplatin for advanced cutaneous squamous cell carcinoma

Also known as: cisplatin

Camrelizumab

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 aged ≥18 years;
• The ECOG score is 0-1, and the ECOG score of amputation patients can be widened to 2, indicating good organ function;
• Histologically determined CSCC with lymph node metastases or distal metastases (class 1) or locally advanced CSCC inoperable/unable to undergo radical radiotherapy (class 2).
• Measurable tumor lesions were assessed by ultrasonography or CT within 21 days before enrollment;
• Estimated survival time ≥3 months.
• Primary tumor site Description: squamous cell carcinoma with primary labial mucosa can be included. Patients with primary SCC in the anogenital region (large and small labia, penis, scrotum, and perianal region) were excluded. The primary site was the nose, and patients were enrolled only if the investigator could definitively identify the primary site as the skin and not the nasal mucosa extending outward into the skin.
• Category 2 only: Cases in which the investigator considers surgery inappropriate include: 1. Recurrent CSCC at the same location after two or more surgical operations and unable to undergo radical resection; 2. Local infiltration of CSCC made complete resection impossible; 3. The location of CSCC lesions is special and the operation is difficult, which may lead to severe defects or dysfunction (such as removing all or part of the facial structure, nose or eye, or requiring amputation); 4. Cases that are not suitable for surgical treatment for other reasons.
• Category 2 only: At least one of the following criteria must be met if the investigator deems radiotherapy inappropriate: 1. The subject has received CSCC radiation therapy such that further radiation therapy would exceed the threshold for acceptable cumulative dose; 2. Subjects were intolerant to radiotherapy; 3. The subject is unwilling to participate in radiotherapy; 4. Cases in which radiotherapy is not suitable for other reasons.
• Tumor histology: Patients with mixed histology (e.g., sarcomatoid carcinoma, adenosquamous carcinoma) are generally not eligible for enrollment. Only when the mixed histology type is mainly mixed basal cell carcinoma and invasive CSCC is the main histological component, the patients can be enrolled after communication with the investigator and approval.
• There was at least one measurable lesion (no previous radiotherapy) according to the response evaluation Criteria for solid tumors, version 1.1 (RECIST V1.1). For nonbody surface lesions, accurate measurement by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast medium is preferred) at baseline showed a long diameter ≥10 mm (except lymph nodes, whose short axis must be ≥15mm), and the lesions were suitable for repeated accurate measurement; For body surface lesions, calipers are required to accurately measure and show their long diameter ≥10 mm and clear lesion edge for repeated and accurate measurement. If the body surface lesions are deeply invasive lesions, CT or MRI is preferred for accurate measurement by referring to non-body surface lesions. A lesion located in a previously irradiated area clearly demonstrated progression that met the RECIST V1.1 criteria (surface lesions must be confirmed as disease progression by biopsy), then the lesion was considered measurable.
• The subject shall consent to biopsy of the target lesion when the investigator deems it necessary for pathological confirmation.
• Previous antitumor therapy was required to meet the following criteria: 1. The interval between systemic radiation therapy and the first dose of the study was ≥3 weeks, and the interval between local radiation therapy or bone metastases was ≥2 weeks. No dose of radiation was taken within 8 weeks before the first dose of this study; 2. The interval between previous chemotherapy and previous targeted therapy and the first administration of this study was ≥4 weeks, or ≥ 5 half-lives of the drug (whichever occurred first); 3. The interval between the first administration of immunotherapy, biologic therapy (tumor vaccine, cytokine or tumour-controlling growth factor), endocrine therapy, tumor embolization or other antitumor therapies including Chinese herbal therapy with antitumor indications was ≥4 weeks;
• Having full organ and bone marrow function, as defined below:
• Blood routine: absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count (PLT) ≥90×109/L; Absolute white blood cell count (WBC) ≥3.0×109/L; Hemoglobin content (HGB) ≥90 g/L. Note: It is not recommended to use G-CSF, GM-CSF, red blood cell transfusion, platelet transfusion and other interventions to reach the normal range within 14 days before examination.
• Liver function: total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); If TBIL \> 1.5×ULN, binding bilirubin ≤ULN; For subjects with liver metastases or a history/suspicion of Gilbert's syndrome (persistent or recurrent hyperbilirubinemia, primarily unbound bilirubin hypertrophy, with no evidence of hemolysis or liver disease). TBIL acuities were 3 x ULN. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤2.5×ULN for subjects without liver metastases; For subjects with liver metastases, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤5×ULN.

You may not qualify if:

• Received other immunomodulator therapy within 4 weeks before the first dose of this study, or had an immune-related adverse event of grade 1 or higher within 90 days before the first dose of this study; Or discontinuation of immunomodulator therapy due to toxicity during previous treatment. These immunomodulators include therapeutic vaccines, cytokine therapy, or immune checkpoint related therapies such as anti-CTLA4 and OX-40.
• Previous antitumor therapy targeting PD-1/PD-L1 signaling pathway;
• Participating in another interventional clinical study, except participating in an observational (non-interventional) clinical study or being in the follow-up phase of an interventional study;
• Received any investigational drug within 4 weeks prior to the initial administration of the investigational drug;
• Use of immunosuppressive drugs within 4 weeks prior to the first administration of the study drug, excluding
• \) intranasal inhaled topical steroid treatment or topical steroid injection (e.g., intra-articular injection); 2) Systemic corticosteroid treatment not exceeding 10 mg/ day of prednisone or its equivalent physiological dose;
• \) Glucocorticoids as prophylaxis for allergic reactions (e.g. pre-CT)
• \. The need for long-term systemic hormone or any other immunosuppressive drug therapy does not include inhaled hormone therapy;
• \. Toxicities due to previous antitumor therapy that did not return to NCI CTCAE V5.0 grade 0 or 1 or the level specified by the enrollment criteria (excluding hair loss, fatigue, or grade 2 or less endocrine related adverse events due to radiation therapy) were present 4 weeks before the first administration of the study drug;
• \. Receive live attenuated vaccine within 4 weeks prior to the first administration of the study drug or planned during the study period;
• \. Had a major surgical procedure (craniotomy, thoracotomy, or laparotomy, or otherwise as defined by the investigator) within 4 weeks prior to the initial administration of the study drug or had an unhealed fracture or was expected to have a major surgery during the duration of the study. Note: Local surgical treatment of isolated lesions is acceptable for palliative care purposes;
• \. No radiographic enhanced radiographic assessment could be performed (either iodine-enhanced CT or gadolinium MRI could be enrolled). If other conditions are met, any contrast-enhanced radiography cannot be accepted, but comprehensive tumor evaluation can be performed by caliper measurement, and the study can be enrolled after communication with the investigator.
• \. Other antitumor therapy (palliative radiotherapy permitted) is anticipated during the trial treatment;
• \. A history of pneumonia requiring hormonal therapy, or interstitial lung disease (including past and present history), with the exception of local interstitial pneumonia due to radiation therapy;
• \. Known central nervous system (CNS) metastases and/or spinal cord compression and/or cancerous meningitis,

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Department of Bone and Soft Tissue ,Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Interventions

camrelizumab; Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 5, 2022
• Study Start: August 5, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: November 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)