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Dabilimab in combination with paclitaxel (albumin-bound) and carboplatin neoadjuvant therapy for local advanced head and neck squamous cell carcinoma: a single-center, single-arm, open, Phase II clinica

Dabilimab in combination with paclitaxel (albumin-bound) and carboplatin neoadjuvant therapy for local advanced head and neck squamous cell carcinoma: a single-center, single-arm, open, Phase II clinica

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091171
Enrollment
Unknown
Registered
2024-10-22
Start date
2024-11-05
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck squamous carcinoma

Interventions

Adbelizumab combined with paclitaxel (albumin-bound) and carboplatin:Dabilimab

Sponsors

The First Affiliated Hospital,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Adults aged 18 to 75, both male and female. 2. All patients must have a pathologically confirmed initial treatment of head and neck squamous cell carcinoma at the First Affiliated Hospital of Sun Yat-sen University, without a history of radiotherapy or chemotherapy for head and neck cancer or immunotargeted drug therapy. 3. Clinical staging: Patients with stage III-IVA/B locally advanced head and neck squamous cell carcinoma (AJCC 8th Edition Staging). 4. According to the RECIST 1.1 tumor evaluation criteria, it has at least one measurable lesion; 5. There was no history of immunosuppressant treatment within 6 months prior to inclusion in the study; 6. Eastern Cooperative Oncology Group physical fitness of all patients The status score is 0 or 1 (on a 5-point scale, with a higher score indicating more severe disability), and organ function is normal. During the study period, patients must submit tumor tissue or blood samples from before treatment. 8. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with distant metastases (screening measures: chest radiograph, PET-CT/MR, abdominal B-ultrasound); 2.Heart, lung and other poor function, hematopoietic dysfunction or other physical factors can not complete the treatment or refuse new supplements Adjuvant chemotherapy, adabilimab and other treatments; 3.Including but not limited to systemic lupus erythematosus, Behcet's disease, Sjogren's syndrome and other known or suspected self People with immune disease, uncontrolled disease, or other active infectious disease; 4.Need to be on immunosuppressive drugs or have a chronic infection (e.g., human immunodeficiency virus, hepatitis B disease) Virus or hepatitis C virus infection) in the active stage of the disease; 5.A history of other malignancies within the previous 5 years (excluding cured cervical carcinoma in situ and skin basal cells) Cancer) or in conjunction with other anti-tumor therapy (including anti-tumor immunotherapy) or participate in other clinical interventions trier; 6.Pregnant and lactating women; 7.Previous allogeneic bone marrow transplantation or solid organ transplantation;

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
2-year local control rate;Progression free survival;Overall survival rate;Complication;

Countries

China

Contacts

Public ContactWenbin Lei

The First Affiliated Hospital,Sun Yat-sen University

leiwb@mail.sysu.edu.cn+86 139 2211 3299

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 29, 2026