Actively Recruiting
Bayesian Adaptive Phase II Trial Comparing Ivonescimab, Ivonescimab Plus Nimotuzumab, Liposomal Mitoxantrone Plus PD-1 Antibody, and Liposomal Irinotecan Plus S-1 for PD-1-Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma
Led by Ming-Yuan Chen · Updated on 2025-09-18
208
Participants Needed
6
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of four different treatment combinations in adults with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have not responded to at least one platinum-based chemotherapy and anti-PD-1/PD-L1 therapy. This phase II trial uses a Bayesian adaptive design to adjust treatment assignments based on patient responses. The study focuses on patients whose cancer cannot be treated with local therapies and have shown resistance to prior immunotherapy. Participants are randomly assigned to one of four treatment groups: Ivonescimab alone, Ivonescimab combined with Nimotuzumab, Liposomal Mitoxantrone combined with an anti-PD-1 antibody, or Liposomal Irinotecan combined with oral S-1. Treatments are given through intravenous infusions or oral medication following specified dosing schedules, with some treatments continuing until disease progression, intolerable side effects, or other study endpoints. The trial includes interim analyses to adjust treatment allocation based on response rates. Patients will have regular visits for monitoring treatment effects, safety, and disease status using imaging and other assessments. Researchers will measure outcomes such as overall response rate, progression-free survival, overall survival, duration of response, disease control rate, adverse events, and quality of life over one year. Participants will remain in the study until disease progression, unacceptable toxicity, withdrawal, or death. The total study duration varies by individual response and treatment course.
CONDITIONS
Brief Title
Combination Therapy for PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma: A Bayesian Adaptive Phase II Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically and/or cytologically confirmed recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (WHO type II or III).
- Aged 18 to 70 years.
- Performance Status score of 0 or 1.
- Disease progression after prior platinum-based doublet chemotherapy.
- Received at least one prior line of systemic therapy.
- Resistance to anti-PD-1 antibody therapy with at least 6 weeks of PD-1 exposure.
- At least one measurable lesion per RECIST 1.1.
- All acute toxicities from prior therapies resolved to grade 1 or lower or meet specified thresholds.
- Adequate organ function including specified blood counts, liver, coagulation, and renal parameters.
- Estimated life expectancy of at least 3 months.
- Signed informed consent and ability to comply with study procedures.
You will not qualify if you...
- Locoregional recurrent lesions treatable by surgery.
- Prior treatment with any study regimen.
- Use of VEGF or VEGFR targeting agents.
- Diagnosis or treatment of other malignancies within 5 years except certain treated cancers.
- Cancer treatments within 4 weeks prior to enrollment (2 weeks for palliative radiotherapy).
- Tumor involvement of internal carotid artery or nasopharyngeal necrosis.
- Significant bleeding events or hemoptysis within 4 weeks prior.
- Active peptic ulcers or recent gastrointestinal surgery; history of serious GI conditions.
- Uncontrolled hypertension or significant recent cardiovascular events.
- History of bleeding disorders or current use of anticoagulants/antiplatelets unless stopped 10 days prior.
- Severe infections or unexplained fever recently.
- Known severe allergies to study drugs.
- Conditions affecting oral drug absorption.
- Recent immunosuppressant or corticosteroid use.
- Active or recent autoimmune diseases likely to recur, except certain exceptions.
- Recent severe respiratory disease exacerbations or active tuberculosis.
- HIV positive or significant viral hepatitis.
- Recent live vaccinations.
- Pregnancy or breastfeeding.
- Women or men unwilling or unable to use contraception.
- Any condition interfering with study results or safety as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies by treatment arm, continuing until disease progression or other discontinuation criteria
Participants receive one of four possible drug regimens, randomized and administered according to assigned treatment arm. Treatment continues until disease progression, intolerable toxicity, withdrawal, initiation of new therapy, loss to follow-up, or death.
Visits every 3 weeks or every 4 weeks depending on treatment regimen, with dosing schedules varying by assigned therapy
Trial Site Locations
Total: 6 locations
1
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China
Not Yet Recruiting
2
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Not Yet Recruiting
4
Zhongshan People's Hospital
Zhongshan, Guangdong, China
Not Yet Recruiting
5
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
Actively Recruiting
6
Xiangya Hospital, Central South University
Changsha, Hunan, China
Not Yet Recruiting
Research Team
M
Mingyuan Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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