Efficacy and Safety of Paclitaxel Polymeric Micelles in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

NCT07662746 | Recruiting Phase 2

• 1 other identifier: SH9H-2026-T347-2
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Paclitaxel polymeric micelles 300 mg/m², IV infusion over ≥3 hours, Day 1; carboplatin AUC 5, IV infusion over 1 hour, Day 1. Each cycle consists of 3 weeks (Q3W), for a total of 3 cycles. (Efficacy assessment will be performed after 3 cycles of treatment. In the absence of disease progression, treatment may be continued until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other antineoplastic therapy, death, or other protocol-specified criteria for treatment discontinuation, whichever occurs first.)

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate

  ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.

  12 months

Secondary Outcomes (3)

• overall survival

  12 months

• Number of Participants Experiencing an Adverse Event (AE)

  12 months

• Progression Free Survival Per RECIST 1.1

  12 months

Study Arms (1)

Paclitaxel polymeric micelles

EXPERIMENTAL

Paclitaxel polymeric micelles for injection 300 mg/m², IV infusion over ≥3 hours, Day 1; carboplatin AUC 5, IV infusion over 1 hour, Day 1. Each cycle consists of 3 weeks (Q3W), for a total of 3 cycles. (Efficacy assessment will be performed after 3 cycles of treatment. In the absence of disease progression, treatment may be continued until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other antineoplastic therapy, death, or other protocol-specified criteria for treatment discontinuation, whichever occurs first.)

Drug: Paclitaxel polymeric micelles

Interventions

Paclitaxel polymeric micelles DRUG

Paclitaxel polymeric micelles for injection 300 mg/m², IV infusion over ≥3 hours, Day 1; carboplatin AUC 5, IV infusion over 1 hour, Day 1. Each cycle consists of 3 weeks (Q3W), for a total of 3 cycles. (Efficacy assessment will be performed after 3 cycles of treatment. In the absence of disease progression, treatment may be continued until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other antineoplastic therapy, death, or other protocol-specified criteria for treatment discontinuation, whichever occurs first.)

Paclitaxel polymeric micelles

Eligibility Criteria

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

You may qualify if:

• Age ≥18 and ≤75 years, male or female; Histologically or cytologically confirmed head and neck squamous cell carcinoma; Prior first-line systemic therapy (including chemotherapy, targeted therapy, and immunotherapy) with disease progression or judged by the clinician to no longer derive clinical benefit; ECOG performance status score of 0-2 and a life expectancy of at least 3 months; At least one measurable lesion on imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1, Appendix 3);
• Adequate major organ function, with subjects meeting the following laboratory parameters:
• Complete blood count meeting the following criteria (no blood transfusion, blood products, granulocyte colony-stimulating factor, or other hematopoietic growth factors within 7 days prior to the test): WBC ≥3.0×10\^9/L, ANC ≥1.5×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥90 g/L; Blood biochemistry meeting the following criteria: total bilirubin ≤1.5×ULN, AST, ALT, or ALP ≤2.5×ULN (for subjects with liver metastases, ALT, AST, or ALP ≤5×ULN is permitted; for subjects with bone metastases, ALP ≤10×ULN is permitted); serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula, Appendix 4) ≥50 mL/min; Adequate coagulation function, defined as INR ≤1.5×ULN and PT or APTT ≤1.5×ULN; Subjects of childbearing potential must agree to use highly effective contraceptive measures during the trial. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of chemotherapy; Good compliance, able to undergo treatment and follow-up, and willing to comply with the study requirements; voluntary signing of the informed consent form.

You may not qualify if:

• Known allergy or intolerance to any study treatment or any excipient; Presence of uncontrolled serious medical conditions, such as severe comorbidities including severe cardiac disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.; Other malignancies within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, or ductal carcinoma in situ after radical surgery; Requirement for concomitant use of other antineoplastic drugs; Receipt of any other investigational drug or participation in another interventional clinical trial within 30 days prior to screening; History of psychotropic substance abuse with inability to abstain, or presence of psychiatric disorders; Pregnant or breastfeeding women; Patients deemed unsuitable for enrollment by the investigator.

Sponsors & Collaborators

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

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

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

CONTACT

13916948812; 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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

CN (1)