De-escalation Radiation Strategy After NAC in Combination With ICI in LAHNSCC

NCT06572514 | Recruiting Phase 1

• 1 other identifier: LAHNSCC-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-arm exploratory study conducted in LAHNSCC. Eligible patients received two cycles of pembrolizumab immunotherapy in combination with albumin-bound paclitaxel and cisplatin induction chemotherapy, followed by definitive concurrent radiochemotherapy. Three months after the completion of radiotherapy, a follow-up examination was conducted, and salvage surgery or systemic therapy was performed as necessary based on the follow-up results.

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Progression-free survival (PFS) (local-regional recurrence) is defined as the time from enrollment to the occurrence of local or regional lymph node recurrence or death for any reason.

  1 year

Secondary Outcomes (4)

• Overall survival (OS)

  3-year

• Clinical response rate

  6 months

• Safety(Grade 3-5 AE)

  1-year

• Quality of life

  6 month and 1 year after the treatment

Study Arms (1)

experimental arm

EXPERIMENTAL

Eligible patients received two cycles of pembrolizumab immunotherapy in combination with albumin-bound paclitaxel and cisplatin induction chemotherapy, followed by definitive concurrent radiochemotherapy.

Drug: immunotherapy：pembrolizumab；chemo：albumin-bound paclitaxel and cisplatin

Interventions

immunotherapy：pembrolizumab；chemo：albumin-bound paclitaxel and cisplatin DRUG

The immunotherapy drug was pembrolizumab at a dose of 200 mg, administered on the first day of each cycle every 3 weeks. The induction chemotherapy regimen included albumin-bound paclitaxel at 260 mg/m2 and cisplatin at 75 mg/m2, given every 3 weeks, either concurrently with immunotherapy or on the second day.

Also known as: definitive radiation

experimental arm

Eligibility Criteria

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

You may qualify if:

• ≥18 years old, with medical decision-making capacity
• Signed informed consent
• ECOG score of 0-1
• Pathologically diagnosed with oral cancer, oropharyngeal cancer, laryngeal cancer, or hypopharyngeal cancer
• Clearly evaluable lesion (per RECIST 1.1 criteria)
• Expected life span ≥6 months
• Laboratory test results meet the following requirements: WBC ≥ 3×10\^9/L, ANC ≥ 2.0×10\^9/L, PLT ≥ 80×10\^9/L, Hb ≥ 80g/L (according to the normal standards of the central laboratory); Liver function: Total bilirubin, ALT, and AST all ≤ 1.5x UNL (upper normal limit); AST (SGOT)/ALT (SGPT) ≤ 2.5 x IULN (upper normal limit); Kidney function: Cr ≤ 1.5x UNL (upper normal limit), and creatinine clearance rate ≥ 60 ml/min (calculated using the Cockcroft and Gault formula); Thyroid function T3 and T4 within the normal range (hypothyroidism can be corrected with oral thyroid hormone supplementation); Heart function: All three cardiac enzymes and pro-BNP within the normal range, no history of heart attack; Adrenal function: Normal cortisol secretion function or correctable based on endocrine assessment
• HBV-infected patients with HBV-DNA copy numbers less than 500 IU/ml
• No history of other malignant tumors in the past 5 years (excluding basal cell carcinoma of the skin and thyroid cancer).

You may not qualify if:

• No indications for curative radiotherapy or contraindications to radiochemotherapy.
• Clinical factors identified by the investigator that could potentially affect the completion of the study protocol (such as bleeding, active infection, or mental factors).
• Patients requiring long-term maintenance steroid therapy (including oral and intravenous use); local use or inhalation can be included in the study.
• History of active tuberculosis or non-infectious pneumonia or any clinical evidence.
• Active phase of viral hepatitis, HBV DNA \> 500 IU/ml.
• Acquired Immunodeficiency Syndrome (AIDS).
• Concurrent severe medical conditions (including heart diseases) with coexisting diseases or conditions affecting the patient's normal enrollment or safety during the study.
• Prior immunotherapy for other tumors.
• History of other malignant tumors within 5 years (excluding cured basal cell carcinoma of the skin or thyroid cancer).
• Pregnant or lactating women.
• Concurrently suffering from other malignant tumors.
• Cannot or unwilling to sign the informed consent form.
• Vaccination within 4 weeks.
• Allergic reaction to the investigational drug.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Interventions

Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Yujie Wang, M.D.

CONTACT

+86 02164370045; wyj12054@rjh.com.cn

Yusheng Gao, M.D.

CONTACT

+86 02164370045; gys11856@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: December 17, 2023
• First Posted: August 27, 2024
• Study Start: October 17, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)