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

Last updated: August 26, 2024
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

1/2

Condition

Head And Neck Cancer

Treatment

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

Clinical Study ID

NCT06572514
LAHNSCC-02
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thecentral 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 T3and T4 within the normal range (hypothyroidism can be corrected with oral thyroidhormone supplementation); Heart function: All three cardiac enzymes and pro-BNPwithin the normal range, no history of heart attack; Adrenal function: Normalcortisol 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 cellcarcinoma of the skin and thyroid cancer).

Exclusion

Exclusion Criteria:

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

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

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

  4. Previous history of autoimmune diseases or in the active phase of the disease [including but not limited to inflammatory bowel disease (IBD), rheumatoidarthritis, autoimmune hepatitis, systemic sclerosis (scleroderma and its variants),systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (suchas Guillain-Barré syndrome)], vitiligo, and correctable endocrine deficiencies suchas hypothyroidism and physiological cortisol deficiency can be included in the studyand are not exclusion criteria.

  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 coexistingdiseases or conditions affecting the patient's normal enrollment or safety duringthe study.

  9. Prior immunotherapy for other tumors.

  10. History of other malignant tumors within 5 years (excluding cured basal cellcarcinoma 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.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: immunotherapy:pembrolizumab;chemo:albumin-bound paclitaxel and cisplatin
Phase: 1/2
Study Start date:
October 17, 2023
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

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