Official Title
A Single-Arm Phase II Clinical Study of Docetaxel Combined With Nimotuzumab and Pucotenlimab as Second-Line and Beyond Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Brief Summary

This study is a single-arm Phase II trial designed to evaluate the efficacy and safety ofDocetaxel, Nimotuzumab, and Pucotenlimab combination therapy in patients with recurrentor metastatic head and neck squamous cell carcinoma who have failed prior PD-1/PD-L1inhibitor and platinum-based therapies, for second-line and later-line treatment.

Detailed Description

Not Provided

Not yet recruiting
Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Drug: Drug Combination Therapy

[Docetaxel 75mg/m2 + Nimotuzumab 400mg + Pucotenlimab 200mg], intravenous infusion, Day
1, every 3 weeks, for 4-6 cycles (exact number determined by investigator assessment).

Maintenance Regimen: [Nimotuzumab 400mg + Pucotenlimab 200mg], intravenous infusion, Day
1, every 3 weeks, until protocol-defined treatment endpoints are reached.

Maintenance Therapy Eligibility: Subjects who meet both criteria after the last induction
cycle: No disease progression confirmed by imaging and investigator assessment, and/or
absence of intolerable toxicity.
Other Name: Docetaxel,Nimotuzumab,Pucotenlimab

Eligibility Criteria

Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, with no
deterioration within 2 weeks prior to enrollment.

2. Age ≥ 18 years and ≤ 75 years

3. Patients with pathologically and/or radiologically confirmed recurrent or metastatic
head and neck squamous cell carcinoma (including oral cavity, oropharynx,
hypopharynx and larynx), who have previously failed treatment with PD-1 (L1)
inhibitors and platinum-based drugs. The two types of drugs could be administered as
a first-line combination regimen or sequential therapy, with the number of prior
treatment lines not exceeding two. If disease progression occurs during neoadjuvant
therapy, concurrent chemoradiotherapy or adjuvant therapy, or within 6 months after
the discontinuation of such treatment, the medications used during neoadjuvant
therapy, concurrent chemoradiotherapy or adjuvant therapy (including platinum-based
drugs, anti-EGFR monoclonal antibodies, PD-1 (L1) inhibitors, etc.) shall be
regarded as first-line treatment. Discontinuation or dose reduction of one drug
during treatment, or replacement of platinum-based drugs, fluorouracil-based drugs
or PD-1 (L1) inhibitors without disease progression shall be counted as the same
line of treatment.

4. At least one radiologically measurable lesion according to RECIST v1.1

5. Assessed by the investigator as not amenable to local therapy (e.g., surgery ±
radiotherapy)

6. PD-L1 Combined Positive Score (CPS) ≥ 1

7. Adequate organ function

8. For women of childbearing potential, the result of serum or urine pregnancy test
within 7 days prior to the first administration of the study drug shall be negative.
If the urine pregnancy test result is positive or cannot be confirmed as negative, a
serum pregnancy test shall be required for confirmation.

9. The patient voluntarily participates in the study, signs the informed consent form,
and is able to comply with the study schedule for follow-up visits, treatment plans,
laboratory tests, and other research procedures.

Exclusion Criteria:

1. A history of malignant tumor is known.

2. Residual toxic reactions caused by prior anti-tumor therapy (including
immunotherapy, targeted therapy, chemotherapy, radiotherapy, etc.) (excluding
alopecia, fatigue and grade 2 hypothyroidism), or clinically significant laboratory
test abnormalities > grade 1 (CTCAE v5.0)

3. Known to have active central nervous system metastases and/or carcinomatous
meningitis. Patients with treated brain metastases may participate in the study,
provided that their disease is stable.

4. A history of severe hypersensitivity reactions to taxanes or other monoclonal
antibodies.

5. Has any contraindication to the study drugs of this project (docetaxel, nimotuzumab,
and camrelizumab)

6. Uncontrolled pleural, peritoneal, pelvic or pericardial effusion requiring drainage
at least once a month.

7. Uncontrolled or poorly controlled heart diseases, including a history of congestive
heart failure (CHF) ≥ Grade 2 (per CTCAE v5.0 or NYHA classification), myocardial
infarction, unstable angina pectoris, ventricular tachycardia or torsades de pointes
within 6 months prior to enrollment, or cardiac arrhythmias requiring treatment,
such as complete left bundle branch block or third-degree atrioventricular block.

8. Pulmonary embolism or deep vein thrombosis occurring within 3 months prior to the
first administration of the study drug (excluding catheter-related thrombosis from
implanted ports or PICC lines)

9. A history of or current interstitial pneumonia, severe chronic obstructive pulmonary
disease complicated with respiratory failure, severe pulmonary insufficiency,
symptomatic bronchospasm, etc.

10. Any severe or uncontrolled systemic diseases, including uncontrolled or poorly
controlled hypertension (e.g., systolic blood pressure > 160 mmHg or diastolic blood
pressure > 100 mmHg), diabetes mellitus (glycated hemoglobin (HbA1c) > 8%), etc.

11. Patients with active bleeding, a history of coagulation disorders, or those
receiving coumarin anticoagulant therapy.

12. Known to have active hepatitis B or hepatitis C.

13. Complicated with severe, uncontrolled infections, or known human immunodeficiency
virus (HIV) infection (positive for HIV antibodies), or diagnosed with acquired
immunodeficiency syndrome (AIDS); or with uncontrolled autoimmune diseases; or with
a history of allogeneic tissue/organ transplantation, stem cell or bone marrow
transplantation, or previous solid organ transplantation.

14. Active bacterial, viral, fungal, rickettsial, or parasitic infections receiving
systemic anti-infective therapy (unless treated and resolved prior to the
administration of the study drug)

15. Live virus vaccines administered within 30 days prior to the first dose of the study
drug. The use of inactivated seasonal influenza vaccines or approved COVID-19
vaccines is permitted, provided that the interval between vaccination and the first
dose of the study drug is more than 1 week.

16. Receiving immunology-based therapy for any reason

17. Pregnant or lactating female patients.

18. Any other diseases, clinically significant laboratory parameter abnormalities,
severe medical or psychiatric illnesses/conditions, or substance abuse including
alcoholism that, in the investigator's judgment, may compromise patient safety,
study integrity, affect patient participation in the study, or interfere with the
study objectives and outcome analysis.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
China
Locations

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China

Investigator: Institutional Review Board of SYSUCC
Contact: 020-87343009
llwyh@sysucc.org.cn

Contacts

Chun-Yan Chen, Prof.
020-87342926
chenchuny@sysucc.org.cn

Not Provided

Sun Yat-sen University
NCT Number
Keywords
R/M HNSCC
Second-line therapy
Immune Checkpoint Inhibitors
Salvage Therapy
MeSH Terms
Squamous Cell Carcinoma of Head and Neck
Drug Therapy, Combination
Docetaxel
nimotuzumab