Irinotecan Liposome Combined with S-1 in PD-1/L1 Inhibitor Refractory Recurrent or Metastatic NPC

NCT06657690 | Recruiting Phase 2 DMC

• 1 other identifier: ZDWY.BYAFZZX.031
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-arm Phase 2 study to evaluate the efficacy and safety of Irinotecan Liposome injection combined with S-1 in patients with recurrent (unable to local curative treatment) or metastatic NPC who failed at least first-line anti-PD-1/L1.

Conditions

Recurrent or Metastatic Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Objective response rate (ORR) is defined as the proportion of patients with a complete response or partial response to treatment

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Progression-free survival (PFS)

  Through study completion, an average of 1 year

• Overall survival (OS)

  Through study completion, an average of 1 year

• Incidence of adverse events

  1 year

Study Arms (1)

Irinotecan liposome group

EXPERIMENTAL

Irinotecan liposome injection combined with S-1 every 4 weeks for up to 6 cycles, until intolerable toxicity, subject withdrawal of informed consent, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first.

Drug: Irinotecan liposome; Drug: S-1

Interventions

Irinotecan liposome DRUG

Irinotecan liposome injection, 50mg/m2, D1、D15, ivgtt, Q4w.

Irinotecan liposome group

S-1 DRUG

S-1, D1-D14, BID, p.o., Q4w (BSA \< 1.25 m2, 40 mg/dose; 1.25 m2 ⩽ BSA \< 1.5 m2, 50 mg/dose; BSA ⩾ 1.5 m2, 60mg/dose).

Irinotecan liposome group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Willing to participate in the study, sign the informed consent form (ICF), and comply with study plan visits, treatment plans, laboratory tests, and other study procedures.
• \. Age ≥ 18 years. 3. Nasopharyngeal carcinoma confirmed by histopathology (differentiated or undifferentiated non-keratinous carcinoma).
• \. Recurrent or metastatic nasopharyngeal carcinoma that has failed at least first-line anti-PD-1/L1, whether or not combined with platinum-containing standard regimen (Anti PD-1/L1 exposure at least 6 weeks, and the protocol used at the time of enrollment in this study meets one of the following two points: (1) Relapse during adjuvant therapy after radiotherapy, or relapse within 6 months after the end of treatment; (2) First-line treatment phase, progression during anti-PD-1/L1 treatment, or progression within 3 months after the end of anti-PD-1/L1).
• \. Recurrent or metastatic nasopharyngeal carcinoma that is unable to local curative treatment (surgery or radiotherapy).
• \. At least one measurable lesion according to RECIST 1.1 criteria (the spiral CT scan diameter of the measurable lesion is ≥ 10 mm or the short diameter of the enlarged lymph node is ≥15mm ); lesions that have undergone local treatment can be selected as target lesions if there is clear evidence of significant progress compared to the end of treatment.
• \. ECOG PS (Eastern Cooperative Oncology Group Performance Status) score 0-1. Expected survival ≥3 months.
• \. Adequate main organ function: a. Liver function: AST and ALT ≤ 2.5 times ULN, bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with known Gilbert disease and serum bilirubin level ≤ 3 times ULN could be enrolled; patients with liver metastasis, ≤ 5 times ULN); b. Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 30 mL/min according to Cockcroft-Gault formula; c. Hematology: neutrophil absolute value (ANC) ≥1.0×10\^9/L, hemoglobin (Hb) ≥ 9.0 g/dL, platelets ≥ 100×10\^9/L.

You may not qualify if:

• \. Severe allergy to Irinotecan liposome (such as systemic rash/erythema hypotension, bronchospasm, angioedema, or anaphylaxis).
• CYP3A4 strong inducer used within 2 weeks, or CYP3A4/UGT1A1 strong suppressor used within 1 week prior to initial administration.
• \. Estimated survival \< 3 months. 4.HBsAg positive and HBV DNA copy number positive (quantitative detection ≥2000 IU/ml); Chronic hepatitis C blood screening positive (HCV antibody positive). Patients with normal liver function and concurrent antiviral therapy were determined by the investigator to be eligible for enrollment.
• \. HIV-positive people. 6. Patients with active bacterial infection, fungal infection, viral infection, or interstitial pneumonia require systemic treatment within 1 week prior to first administration.
• \. Received chemotherapy, targeted therapy, immunotherapy, or any investigational drug or other antitumor therapy within 4 weeks or 5 half-lives before first administration (whichever is shorter but at least 2 weeks).
• \. Received Chinese medicine with antitumor activity within 14 days before administration; Received other investigational drugs within 4 weeks prior to initial dosing.
• \. Patients who had undergone major surgery within 3 months prior to initial dosing or planned to undergo major surgery during the study period.
• \. Severe embolic events, such as cerebrovascular accidents (including transient ischemic attacks) and pulmonary embolism, occurred in the 6 months before screening.
• \. Diagnosed and/or treated with other malignancies within 2 years before initial administration (except for curable malignancies that have undergone radical treatment, such as skin basal cell, carcinoma in situ of the cervix, papillary thyroid cancer, etc).
• \. Severe cardiovascular disease during the 6 months before enrollment, including but not limited to the following: Acute myocardial infarction, unstable angina pectoris, coronary angioplasty or stenting, deep vein thrombosis, stroke; New York Heart Association Class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) \< 50%; According to the investigator's assessment, clinically significant abnormal electrocardiogram (ECG) at the time of screening.
• \. Pregnant or lactating women. 14. Serious dysfunction of heart, lung, liver, kidney, and other vital organs; serious and/or uncontrollable disease that may affect the patient's participation in the study (including, but not limited to, uncontrolled diabetes, life-threatening autoimmune and bleeding disorders, substance abuse, neurological disorders, etc.).
• \. Other situations that the investigator determines to be inappropriate for participation.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Fifth affiliated hosptial of Sun-yat Sen university

Zhuhai, Guangzhou, 519000, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Nasopharyngeal Carcinoma

Interventions

irinotecan sucrosofate; S 1 (combination)

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Mingyuan Chen, MD, PhD

CONTACT

18124188280; chmingy@mail.sysu.edu.cn

Rui You, MD, PhD

CONTACT

13580439820; your5@mail.sysu.edu.cn

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: Chief physician, Professor

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: January 10, 2025

Record last verified: 2024-10

Locations

CN (1)