SCT200 Plus Platinum-based Chemotherapy in Head and Neck Squamous Cell Carcinoma

NCT03874741 | Unknown Phase 2

• 1 other identifier: SCT200-B202
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of first-line with recombinant anti-EGFR monoclonal antibody#SCT200#and standard chemotherapy in patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and Neck Cancer; Epidermal growth factor receptor; SCT200

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment.

  1 year

Secondary Outcomes (6)

• Disease control rate (DCR)

  1 year

• Progresssion free survival(PFS)

  1 year

• Overall survival(OS)

  1 year

• Immunogenicity

  1 year

• EORTC QLQ-C30

  1 year

Study Arms (1)

Arm - Experimental

EXPERIMENTAL

Anti-EGFR monoclonal antibody DDP(75mg/m2),d1; 5-FU(750mg/m2),d1-5, every 21d; PF chemothrapy up to 6 cycles. 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression.

Drug: SCT200

Interventions

SCT200 DRUG

Anti-EGFR monoclonal antibody DDP(75mg/m2),d1; 5-FU(750mg/m2),d1-5, every 21d; PF chemothrapy up to 6 cycles. 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression Other Names: • SCT200

Also known as: Anti-EGFR monoclonal antibody

Arm - Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in this clinical trial and sign an informed consent form;
• Male or female, age ≥ 18 and ≤ 75 years old;
• ECOG fitness status score 0 to 1;
• Recurrent and/or metastatic HNSCC (except nasopharyngeal carcinoma) diagnosed by pathology #
• Not suitable for topical treatment. Patients with only recurrent disease (no metastasis) must have received radiotherapy (as post-operative adjuvant therapy or as a treatment for locally advanced HNSCC) as a "localized area treatment" and radiotherapy must be completed at least 6 months prior to screening imaging#
• Laboratory inspection:
• Blood routine: neutrophils ≥1.5×l09/L, platelets≥75×109/L, hemoglobin≥80g/L;
• Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ALT and AST ≤ upper limit of normal value × 3 for liver metastasis, ALT and AST ≤ upper limit of normal value for liver metastases × 5; total bilirubin ( TBIL) ≤ upper limit of normal value × 2.0;
• Renal function: creatinine (Cr) ≤ normal upper limit × 1.5;
• Electrolyte: Magnesium ≥ normal lower limit;
• According to the RECIST standard version 1.1, there is at least one measurable tumor lesion.

You may not qualify if:

• Patients with a history of central nervous system metastasis or a history of central nervous system metastasis before screening. For patients with clinically suspected central nervous system metastasis, imaging confirmation must be performed within 28 days prior to enrollment to exclude central nervous system metastasis;
• Received systemic chemotherapy for advanced or metastatic HNSCC, but do not include induction chemotherapy, concurrent chemoradiotherapy or adjuvant chemotherapy (the end of this treatment must be more than 6 months from the first trial);
• There are other medical history of malignant tumors, except that the malignant lesions have been treated with therapeutic measures 5 years or more before enrollment and there are no known active lesions. The investigator judges that the risk of recurrence is low; Non-melanoma skin cancer, and no evidence of worsening disease; adequately treated cervical cancer in situ, and no evidence of worsening disease; prostatic intraepithelial neoplasia, no evidence of prostate cancer recurrence;
• known to be allergic to antibodies or other components contained in the test drug;
• have received EGFR antibodies (such as panitumumab, cetuximab or its analogs), or small molecule EGFR inhibitors (such as gefitinib, erlotinib, lapatinib, etc.);
• In the 4 weeks or 4 weeks before enrollment, they received anti-tumor drugs (such as chemotherapy, hormone therapy, immunotherapy, antibody therapy, radiotherapy, etc.) or received research drug treatment and could not be included in the evaluation by the investigator. Pain-free palliative radiotherapy for bones;
• At the time of enrollment, patients still had ≥2 peripheral neuropathy or hearing loss;
• Patients have been enrolled in other study devices or study drug studies at screening time, or have been deactivated for less than or equal to 4 weeks from other study drugs or study devices;
• Conduct or plan major surgery within 4 weeks prior to enrollment;
• Received transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GMCSF) within 2 weeks prior to enrollment;
• Clinically significant cardiovascular disease (defined as: unstable angina, symptomatic congestive heart failure (New York Heart Association \[NYHA\]
• ≥ II), uncontrollable severe arrhythmia);
• Myocardial infarction occurred within 6 months prior to enrollment;
• History of interstitial lung disease (ILD), such as interstitial pneumonia, pulmonary fibrosis, or evidence of ILD on baseline chest CT or MRI;
• have clinical symptoms, require clinical intervention or serous effusion (such as pleural effusion and ascites) with a stabilization time of less than 4 weeks;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Cancer hospital Chinese academy of medical sciences

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Study Officials

• Yuankai Shi, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 14, 2019
• Study Start: May 21, 2019
• Primary Completion: June 30, 2020
• Study Completion: July 1, 2021
• Last Updated: May 27, 2020

Record last verified: 2020-05

Locations

CN (1)