Trial Title:
Irinotecan Liposome Combined with S-1 in PD-1/L1 Inhibitor Refractory Recurrent or Metastatic NPC
NCT ID:
NCT06657690
Condition:
Recurrent or Metastatic Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Recurrence
Irinotecan
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Irinotecan liposome
Description:
Irinotecan liposome injection, 50mg/m2, D1、D15, ivgtt, Q4w.
Arm group label:
Irinotecan liposome group
Intervention type:
Drug
Intervention name:
S-1
Description:
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).
Arm group label:
Irinotecan liposome group
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.
Detailed description:
Fifty-six recurrent (unable to local curative treatment) or metastatic NPC patients who
had failed at least first-line anti-PD-1/L1, whether or not combined with chemotherapy,
were eligible to receive Irinotecan Liposome injection combined with S-1 for up to 6
cycles. All patients will be treated until disease progression as determined by the
investigator based on RECIST 1.1 criteria, intolerable toxicity, subject withdrawal of
informed consent, initiation of new antitumor therapy, loss of follow-up, death, or study
completion, whichever occurs first. Regular visits and imaging examinations will be
conducted to evaluate the efficacy and safety of the treatment regimen.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. 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.
2. Age ≥ 18 years. 3. Nasopharyngeal carcinoma confirmed by histopathology
(differentiated or undifferentiated non-keratinous carcinoma).
4. 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).
5. Recurrent or metastatic nasopharyngeal carcinoma that is unable to local
curative treatment (surgery or radiotherapy).
6. 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.
7. ECOG PS (Eastern Cooperative Oncology Group Performance Status) score 0-1.
Expected survival ≥3 months.
8. 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.
Exclusion Criteria:
-
1. Severe allergy to Irinotecan liposome (such as systemic rash/erythema
hypotension, bronchospasm, angioedema, or anaphylaxis).
2.CYP3A4 strong inducer used within 2 weeks, or CYP3A4/UGT1A1 strong suppressor used
within 1 week prior to initial administration.
3. 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.
5. 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.
7. 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).
8. Received Chinese medicine with antitumor activity within 14 days before
administration; Received other investigational drugs within 4 weeks prior to
initial dosing.
9. Patients who had undergone major surgery within 3 months prior to initial
dosing or planned to undergo major surgery during the study period.
10. Severe embolic events, such as cerebrovascular accidents (including transient
ischemic attacks) and pulmonary embolism, occurred in the 6 months before
screening.
11. 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).
12. 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.
13. 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.).
15. Other situations that the investigator determines to be inappropriate for
participation.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fifth affiliated hosptial of Sun-yat Sen university
Address:
City:
Zhuhai
Zip:
519000
Country:
China
Status:
Recruiting
Contact:
Last name:
Mingyuan Chen, MD, PhD
Phone:
18124188280
Email:
chmingy@mail.sysu.edu.cn
Start date:
November 1, 2024
Completion date:
October 31, 2027
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06657690
