Neoadjuvant Cadonilimab in Combination With Cisplatin and Nab-paclitaxel in Resectable Head and Neck Squamous Cell Carcinoma

NCT06023875 | Unknown Phase 2

• 1 other identifier: 2023-FXY-011-HNC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a single arm phase ll trial including 30 patients with T2N2-3M0、T3-4N0-3M0 (lll-V) head and neck squamous cell carcinoma (HNSCC) eligible forresection, who receive neo-adjvuant Cadonilimab combined with cisplatin and Nab.paclitaxel.This proposed study will evaluate the efficacy and safety of preoperativeadministration of Cadonilimab combined with chemotherapy in Head and Neck Squamous Cell Carcinoma (HNSCC) who are about to undergo surgery.

Conditions

Head and Neck Squamous Cell Carcinoma; Locally Advanced Operable

Keywords

head and neck squamous cell carcinoma; Cadonilimab; neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• ORR

  overall response rate

  9 weeks

Secondary Outcomes (6)

• PCR

  9 weeks

• MPR

  9 weeks

• DCR

  2 years

• PFS

  2 years

• OS

  5 years

Study Arms (1)

Experimental group

EXPERIMENTAL

Patients with locally advanced operable head and neck squamous cell carcinoma

Drug: Cadonilimab; Drug: Docetaxel; Drug: Cisplatin

Interventions

Cadonilimab DRUG

Cadonilimab 10mg/kg. The drug was administered every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. The treatment regimen is recommended for three cycles until the researchers determine that the subjects cannot continue to benefit, until the disease progression (PD), the toxicity cannot be tolerated, the treatment is delayed by more than 14 days, or the patient withdraws the informed consent form or dies.

Also known as: AK104

Experimental group

Docetaxel DRUG

Docetaxel 75mg/m2. Intravenous infusion was given every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. Treatment regimen is recommended for 3 cycles.

Experimental group

Cisplatin DRUG

Cisplatin 60mg/m2. Intravenous infusion was given every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. Treatment regimen is recommended for 3 cycles.

Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed primary head and neck squamous cell carcinoma confirmed by histology and/or cytology (excluding diagnostic therapy).
• Clinical stage: T2N2-3M0, T3-4N0-3M0 (III-IV) (AJCC 8th edition staging).
• Age: 18 to 70 years.
• PS score (see Appendix Table 1; performance status score of 0 or 1).
• Patients evaluated by a head and neck oncologist as resectable with no distant metastases.
• Patients with at least one measurable lesion according to RECIST version 1.1 criteria.
• Patients' toxicities assessed according to CTCAE version 4.03 criteria.
• Patients with normal organ function (heart, brain, lungs, kidneys) and suitable for surgery:
• Hematology: White blood cells ≥ 4000/μL, neutrophils ≥ 2,000/μL, hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/μL;
• Liver function: Bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin levels ≤ 3 times ULN can be included), AST and ALT ≤ 3 times ULN, alkaline phosphatase ≤ 3 times ULN; albumin ≥ 3 g/dL;
• Renal function: Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min according to Cockcroft-Gault formula.
• Consent to provide archived tumor tissue samples or undergo biopsy for collection of tumor lesion tissue (at least 3 unstained FFPE pathological slides, if deemed insufficient for PD-L1 IHC testing by the central laboratory, an additional 3 unstained FFPE pathological slides should be provided) to be sent to the central laboratory for PD-L1 immunohistochemistry (IHC) testing (preferably using recently obtained tumor tissue samples). Tumor lesions planned for biopsy should not be used for assessing target lesions of the disease unless no other suitable lesions for biopsy are available. Patients have signed an informed consent form, are willing and able to comply with the study's visit, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

• History of severe hypersensitivity reactions to components of other monoclonal antibodies, CTLA4, or PD-1 antibodies.
• Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures.
• Recurrence, distant metastasis, or the inability to undergo surgery as assessed by a head and neck physician.
• Abnormal coagulation function: (PT \> 16s, APTT \> 53s, TT \> 21s, Fib \< 1.5g/L), bleeding tendency, or currently on anticoagulant or thrombolytic therapy.
• Severe heart disease, pulmonary dysfunction, patients with heart or lung function below Grade 3 (including Grade 3).
• Laboratory values not meeting relevant criteria within 7 days prior to enrollment.
• Previous use of anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibodies targeting T cell co-stimulation or checkpoint pathways).
• Pre-existing conditions requiring long-term use of immunosuppressive drugs or a need for systemic or local use of corticosteroids at immunosuppressive doses prior to enrollment.
• HIV-positive individuals; HBsAg-positive individuals with positive HBV DNA copy number (quantitative test ≥ 1000 cps/ml); positive chronic hepatitis C blood screening (HCV antibody positive).
• Traditional herbal medicine used for anti-tumor purposes within 4 weeks before randomization.
• Active or prior history of documented inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea).
• Women of childbearing potential with a positive pregnancy test and breastfeeding women.
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Severe infection occurring within 4 weeks before the first administration, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia.
• Subjects planning major surgery within 30 days after the first dose of AK104 in combination with platinum-containing dual-agent therapy (as determined by the investigator), or not yet fully recovered from prior surgery. Local surgical procedures (such as placement of a systemic port and prostate biopsy) are allowed provided that the surgery is completed at least 24 hours before the first dose of the study treatment.

Sponsors & Collaborators

• Xuekui Liu: lead

Study Sites (2)

Sun Yat-sen University Cancer Center, 651 Dongfeng East Road

Guangzhou, Guangdong, 510060, China

RECRUITING

Sun Yat-sen University Cancer Center, 651 Dongfeng East Road

Guangzhou, China

RECRUITING

Related Publications (1)

• Cao F, Li Y, Fang Q, Lin R, Zhao Z, Xu P, Yan H, Zhang X, Jiang K, Zhou J, Chen C, Lu L, Han F, Li Z, Wu D, Liu X. Cadonilimab (a PD-1/CTLA-4 Bispecific Antibody) plus Neoadjuvant Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Phase II Clinical Trial. Clin Cancer Res. 2025 Sep 15;31(18):3876-3885. doi: 10.1158/1078-0432.CCR-25-1445.

  PMID: 40705040 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

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

Central Study Contacts

Xuekui Liu

CONTACT

+8613609713406; liuxk@sysucc.org.cn

Study Design

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

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 5, 2023
• Study Start: July 19, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)