Adelbelimab Combination Chemotherapy in Neoadjuvant Therapy for Squamous Cell Carcinoma of the Head and Neck
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ClinicalTrials.gov Identifier: NCT06016413 |
Recruitment Status :
Not yet recruiting
First Posted : August 29, 2023
Last Update Posted : August 29, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Squamous Cell Carcinoma | Drug: Nab paclitaxel Drug: Carboplatin Drug: adelbelimumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Single-arm, Phase II Study of Adelbelimab Combined With Carboplatin and Nab-paclitaxel in Neoadjuvant Therapy for Patients With Resectable Locally Advanced Squamous Cell Carcinoma of the Head and Neck |
Estimated Study Start Date : | September 1, 2023 |
Estimated Primary Completion Date : | December 1, 2024 |
Estimated Study Completion Date : | December 1, 2026 |
Arm | Intervention/treatment |
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Experimental: intervention group
All patients received nab-paclitaxel 260 mg/m2, carboplatin AUC=5 and adelbelimumab 1200 mg intravenously on day 1 of each 3-week cycle for 3 cycles. All patients were given conventional drugs to prevent vomiting in each cycle, and intravenous dexamethasone was given to prevent allergy before each dose
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Drug: Nab paclitaxel
All patients received nab-paclitaxel 260 mg/m2 intravenously on day 1 of each 3-week cycle for 3 cycles. Drug: Carboplatin All patients received carboplatin AUC=5 intravenously on day 1 of each 3-week cycle for 3 cycles. Drug: adelbelimumab All patients received carboplatin AUC=5 intravenously on day 1 of each 3-week cycle for 3 cycles. |
- Postoperative pathological complete response rate [ Time Frame: one week after operative ]The postoperative specimens were sent to the pathology department for fixation, sectioning, and observation. Two pathologists judge whether the subject's tumor remains. If there is a disagreement between the two, the third senior pathologist will discuss and decide
- Major pathological response rate [ Time Frame: one week after operative ]The postoperative specimens were sent to the pathology department for fixation, sectioning, and observation. Two pathologists judge whether the subject's tumor remains. If there is a disagreement between the two, the third senior pathologist will discuss and decide
- Two years overall Survival [ Time Frame: Two years after investigator enrollment ]
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age between 18-75 years old
- According to the 8th edition of the guidelines of the American Joint Committee on Cancer (AJCC), patients with stage III-IVB tumors of non-oropharyngeal cancers confirmed by pathology as head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx or larynx) and HPV-negative oropharyngeal cancer patients, or HPV-positive oropharyngeal cancer patients with stage II-III tumors
- Resectable tumors were evaluated by head and neck surgeons before enrollment to exclude clinical evidence of distant metastasis
- According to RECIST 1.1, there is at least one measurable tumor lesion
- The performance status of the Eastern Cooperative Oncology Group (ECOG) is 0-1
- Blood routine: white blood cell count (WBC) ≥ 3.0×109/L; absolute neutrophil count (ANC) ≥ 1.5×109/L; platelet (PLT) ≥ 100×109/L; hemoglobin level (HGB) ≥ 9.0 g/dL (without corresponding supportive treatment such as blood transfusion and leukocytosis within 7 days).
- Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in patients without liver metastasis ≤ 2.5 times the upper limit of the reference value (ULN); albumin (ALB) ≥ 30 g /L.
- Renal function: serum creatinine ≤ 1.5 times ULN or creatinine clearance (CrCl) ≥ 50mL/min (using the Cockcroft/Galter formula); urine protein (UPRO) < (++), or 24 Hourly urine protein < 1.0 g.
- Determination of HPV status in oropharyngeal cancers using p16 IHC. A sample was considered p16 positive if >70% of tumor cells exhibited intense diffuse nuclear and cytoplasmic staining
- Have not participated in other clinical trial projects in the past 30 days;
- Patients who voluntarily participate in the project and sign the informed consent.
Exclusion Criteria:
- The patient has abnormal blood indicators, abnormal liver and kidney function, and cannot tolerate the clinical research process after multidisciplinary consultation evaluation
- The patient has previously suffered from other tumors, or has previously undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy
- The entire clinical research process cannot be completed due to personal, social and economic reasons
- Serious systemic diseases in the past and the diseases cannot be cured or controlled by drugs -
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06016413
Contact: Zhiquan Huang | 13826142898 | hzhquan@mail.sysu.edu.cn |
China, Guangdong | |
Sun Yat-sen Memorial Hospital | |
Guangzhou, Guangdong, China, 510120 | |
Contact: Zhiquan Huang 02081332471 hzhquan@mail.sysu.edu.cn |
Responsible Party: | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
ClinicalTrials.gov Identifier: | NCT06016413 |
Other Study ID Numbers: |
SYSKY-2023-616-02 |
First Posted: | August 29, 2023 Key Record Dates |
Last Update Posted: | August 29, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
head and neck squamous cell carcinoma immunity therapy PD-L1 |
Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Head and Neck Neoplasms Neoplasms by Site |
Paclitaxel Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |