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

NCT ID: NCT06572514

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-17
• Study Completion Date: 2027-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental arm

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DRUG

Other Intervention Names

definitive radiation

Eligibility Criteria

Inclusion Criteria

1. ≥18 years old, with medical decision-making capacity

2. Signed informed consent

3. ECOG score of 0-1

4. Pathologically diagnosed with oral cancer, oropharyngeal cancer, laryngeal cancer, or hypopharyngeal cancer

5. Exclusion of distant metastasis

6. Clearly evaluable lesion (per RECIST 1.1 criteria)

7. Expected life span ≥6 months

8. 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

9. HBV-infected patients with HBV-DNA copy numbers less than 500 IU/ml

10. No history of other malignant tumors in the past 5 years (excluding basal cell carcinoma of the skin and thyroid cancer).

Exclusion Criteria

1. No indications for curative radiotherapy or contraindications to radiochemotherapy.

2. Clinical factors identified by the investigator that could potentially affect the completion of the study protocol (such as bleeding, active infection, or mental factors).

3. Patients requiring long-term maintenance steroid therapy (including oral and intravenous use); local use or inhalation can be included in the study.

5. History of active tuberculosis or non-infectious pneumonia or any clinical evidence.

6. Active phase of viral hepatitis, HBV DNA > 500 IU/ml.

7. Acquired Immunodeficiency Syndrome (AIDS).

8. Concurrent severe medical conditions (including heart diseases) with coexisting diseases or conditions affecting the patient's normal enrollment or safety during the study.

9. Prior immunotherapy for other tumors.

10. History of other malignant tumors within 5 years (excluding cured basal cell carcinoma of the skin or thyroid cancer).

11. Pregnant or lactating women.

12. Concurrently suffering from other malignant tumors.

13. Cannot or unwilling to sign the informed consent form.

14. Vaccination within 4 weeks.

15. Allergic reaction to the investigational drug.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

GAOYUNSHENG

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yujie Wang, M.D.

Role: CONTACT

wyj12054@rjh.com.cn

+86 02164370045 ext. 602400

Yusheng Gao, M.D.

Role: CONTACT

gys11856@rjh.com.cn

+86 02164370045 ext. 602400

Facility Contacts

Yunsheng Gao, M.D.

Role: primary

gys11856@rjh.com.cn

+86-021-64370045 ext. 602400

Other Identifiers

LAHNSCC-02

Identifier Type: -

Identifier Source: org_study_id