Clinical Study of Mitoxantrone Hydrochloride Liposome Combined with PD-1 Blockade in Recurrent or Metastatic NPC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMing-Yuan Chen
About this trial
This is a prospective, single-arm Phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection combined with PD-1 blockade in patients with recurrent (not unable to locally curative treatment) or metastatic NPC who failed at least first-line platinum-containing standard regimen and/or anti PD-1/L1.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Nasopharyngeal carcinoma confirmed by histopathology (differentiated or undifferentiated non-keratinous carcinoma).
Age ≥ 18 & ≤ 70 years.
PS (Performance Status) score 0-1.
Disqualifiers
Adequate main organ function. a. Hematology: neutrophil absolute value (ANC) ≥1.5×10^9/L, hemoglobin (Hb) ≥ 9.0 g/dL, platelets ≥ 100×10^9/L; b. Liver function: 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), AST and ALT ≤ 3 times ULN, and alkaline phosphatase ≤ 3 times ULN; Albumin ≥ 3 g/dL; c. International Normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 times; d. Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 mL/min according to Cockcroft-Gault formula; e. Proteinuria: urinary protein/creatinine ratio (UPC ratio) < 1.0. If the UPC ratio is less than or equal to 0.5, no further check is required. Patients with UPC ratio > 0.5 and those with 24-hour urinary protein < 1000 mg could be enrolled; f. Note: The UPC ratio of random urine is a quantitative estimate of 24-hour urinary protein, and the two have a good correlation. UPC ratio can be calculated using the following formula: (a) Urinary protein/urinary creatinine (if both protein and creatinine are mg/dL); (b) (urinary protein)*0.088/ urinary creatinine (if urinary creatinine is mmol/L).
Survival is expected to be ≥ 3 months.
Female subjects with negative blood human chorionic gonadotropin (HCG) (except for menopause and hysterectomy), female subjects of reproductive age and their partners using effective contraception during the trial period and within 6 months after the end of the last dose (e.g. Combined hormones [containing estrogen and progesterone combined to inhibit ovulation, progesterone contraception combined to inhibit ovulation, IUD, intrauterine hormone release system, bilateral tubal ligation, vasectomy, abstinence from sex, etc.).
Male patients and their partners agree to use one of the contraceptive measures described in Article 9.
Trial design
Design model
Single group
Treatments tested in this trial
Mitoxantrone hydrochloride liposome injection
DrugMitoxantrone hydrochloride liposome injection once every 3 weeks for up to 8 cycles or until intolerable toxicity, subject withdrawal of informed consent, diseases progression, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first.
PD-1 Inhibitors
DrugPD-1 blockade (comprising tislelizumab \<200 mg/cycle\>, carrellimab \<200 mg/cycle\>, or toripalimab \<240 mg/cycle\>) once every 3 weeks for two years, or until intolerable toxicity, subject withdrawal of informed consent, diseases progression, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Mitoxantrone groupExperimental treatment 2 interventions
Trial outcomes
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
Time frame
Through study completion, an average of 2 yearsSecondary outcomes
1
Duration of Response (DOR)
Duration of Response (DOR) is defined as time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death
Time frame
Through study completion, an average of 2 years2
Disease control rate (DCR)
Disease Control Rate (DCR) is defined as the percentage of patients who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents
Time frame
Through study completion, an average of 2 years3
Progression-free survival (PFS)
Progression-Free Survival PFS is defined as the time from randomization to progression or death
Time frame
Through study completion, an average of 2 years4
Overall survival (OS)
Overall survival (OS) is defined as the duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death.
Time frame
Through study completion, an average of 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ming-Yuan Chen
Lead sponsor
Sun Yat-sen University
Sponsor institution
Source ClinicalTrials.gov