Camrelizumab Plus Docetaxel and Cisplatin in Recurrent or Metastatic Oral Squamous Cell Carcinoma Patients

NCT05611463 | Unknown Phase 2 DMC

• 1 other identifier: SH9H-2019-T354-2
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

the purpose of this study is to assess the efficacy and safety of camrelizumab plus Docetaxel and Cisplatin as First-line Therapy in Recurrent or Metastatic Oral Squamous Cell Carcinoma Patients

Conditions

Oral Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Participants Experiencing an Adverse Event (AE)

  An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that experienced at least one AE was reported for treatment arm

  24 months

Secondary Outcomes (4)

• Objective remission rate (ORR)

  24 months

• overall survival

  24 months

• progression -free survival

  the time from enrolled to radiographically confirmed disease progression or death from any cause (whichever occurred first)

• Duration of remission (DOR)

  24 months

Study Arms (1)

Camrelizumab Plus Docetaxel and Cisplatin

EXPERIMENTAL

Participants receive Camrelizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 24 months;plus cisplatin 75 mg/m\^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum); plus docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle (6 cycle maximum).

Drug: Camrelizumab Plus Docetaxel and Cisplatin

Interventions

Camrelizumab Plus Docetaxel and Cisplatin DRUG

Camrelizumab (200 mg) was administered once on day 1 every 3 weeks until disease progression, intolerable toxicity, physician or participant decision or 35 cycles, whichever occurred first. Chemotherapy was received docetaxel (75 mg/m2) and cisplatin (75 mg/m²) on day 2 every 3 weeks for six cycles.

Also known as: SHR-1210+DTX+Platinol

Camrelizumab Plus Docetaxel and Cisplatin

Eligibility Criteria

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

You may qualify if:

• Patients with histologically confirmed post-surgical recurrent/metastatic or locally advanced inoperable oral squamous carcinoma with measurable lesions (spiral CT scan ≥ 10 mm, meeting RECIST 1.1 criteria).
• No prior treatment with any systemic antineoplastic agent, prior adjuvant or neoadjuvant therapy (other than PD-1/PDL-1 monoclonal antibody) is allowed, provided that it was completed at least 4 weeks prior to the first dose of study drug and all associated toxic events have returned to normal or to grade I or below as defined by CTCAE 4.03 classification.
• An ECOG score of 0 or 1.
• Expected survival of ≥ 12 weeks.
• Normal function of major organs within 2 weeks prior to treatment, i.e. meeting the following criteria.
• Bone marrow function: hemoglobin ≥ 100gg/L, white blood cell count ≥ 4.0\*10\^9/L or neutrophil count ≥ 2.0\*10\^9/L and platelet count ≥ 100\*10\^9/L without transfusion or with colony-stimulating factor support therapy.
• Liver: serum total bilirubin level ≤ 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal.
• Renal: blood creatinine level less than 1.5 times the upper limit of normal or creatinine clearance ≥ 60 ml/min and urea nitrogen ≤ 200 mg/L. Urine protein \<+, if urine protein + then total 24 hour protein must be \<500mg.
• Blood glucose: within normal range and/or with diabetic patients on treatment but with stable blood glucose control.
• Pulmonary function: baseline FEV1 of at least 2L, if baseline FEV1 \< 2L, FEV1 \>800ml is expected after surgery as assessed by a surgical specialist.
• Cardiac function: no myocardial infarction within 1 year; no unstable angina; no symptomatic severe arrhythmia; no cardiac insufficiency.
• Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to the first dose of the test drug; men of childbearing potential or women of childbearing potential must use a highly effective contraceptive method (e.g., oral contraceptive pill, intrauterine device, abstinence from sexual intercourse, or barrier contraceptive method combined with spermicide) throughout the trial and continue to use contraception for 12 months after the end of treatment.

You may not qualify if:

• Patients with prior anti-PD-1, anti-PD-L1, anti-PD-L2 therapy. Patients who are currently receiving antineoplastic therapy.
• Patients who have participated or are participating in a clinical trial of another drug/therapy within 4 weeks prior to the first dose of the study drug.
• Patients with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma that has completely resolved in childhood and does not require any intervention in adulthood may be included; patients who require medical intervention with bronchodilators (asthma, on the other hand, cannot be included).
• Patients who are on immunosuppressive, or systemic hormone therapy for immunosuppressive purposes (doses \>10 mg/day prednisone or other equipotent hormone) and are continuing to use them within 2 weeks prior to enrollment.
• Patients who have received hematopoietic stimulating factors, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc., within 1 week prior to the first administration of the study drug.
• Positive test results for HIV antibodies or syphilis spirochete antibodies. Patients with active hepatitis B or C:
• If HBsAg or HBcAb is positive, add HBV DNA test (the result is higher than the upper limit of the normal range).
• Additional HCV RNA testing if positive for HCV antibodies (results above the upper limit of the normal range).
• Persons with known hypersensitivity to recombinant humanized PD-1 monoclonal antibody drugs and their components.
• Massive pleural or ascites fluid with clinical symptoms and requiring symptomatic management.
• Active lung disease (interstitial pneumonia, pneumonia, obstructive lung disease, asthma) or a history of active tuberculosis.
• Have any clinical problems beyond their control, including but not limited to: Persistent or active (severe) infection;
• Poorly controlled diabetes;
• Cardiac disease (Class III/IV congestive heart failure or heart block as defined by the New York Heart Association);
• Have or suspect autoimmune disease, or a history of autoimmune disease or syndrome requiring steroid/immunosuppressive systemic therapy, such as: hypopituitaritis, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc;

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

camrelizumab; Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Yue He, M.D.

  the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoxin Ren, PHD

CONTACT

021-23271699; renguoxincn@sina.com

Study Design

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

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: November 10, 2022
• Study Start: June 2, 2020
• Primary Completion: December 2, 2022
• Study Completion: June 2, 2023
• Last Updated: November 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)