Actively Recruiting
Combination Therapy for PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma: A Bayesian Adaptive Phase II Trial
Led by Ming-Yuan Chen · Updated on 2025-09-18
208
Participants Needed
6
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, Bayesian adaptive, phase II clinical trial designed to evaluate the safety and efficacy of four treatment regimens in patients with recurrent (unamenable to local therapy) or metastatic nasopharyngeal carcinoma (NPC) who have failed after at least one prior platinum-containing standard regimen and anti-PD-1/PD-L1 therapy. The four treatment arms include: 1. Ivonescimab monotherapy, 2. Ivonescimab combined with nimotuzumab, 3. Liposomal mitoxantrone plus anti-PD-1 antibody, and 4. Liposomal irinotecan plus S-1.
CONDITIONS
Official 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 or cytologically confirmed recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (WHO type II or III).
- Age between 18 and 70 years.
- Performance Status score of 0 or 1.
- Disease progression after prior platinum-based doublet chemotherapy.
- Received at least one prior systemic therapy line.
- Resistance to anti-PD-1 antibody therapy with at least 6 weeks of exposure.
- At least one measurable lesion by RECIST 1.1 criteria.
- All acute toxicities from prior treatments resolved to grade 1 or less or meet specified thresholds.
- Adequate organ function including blood counts, liver, coagulation, and kidney function within specified limits.
- 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 amenable to curative treatment such as surgery.
- Prior treatment with any study regimen.
- Prior use of agents targeting VEGF or VEGFR.
- Diagnosis or treatment of another malignancy within 5 years except certain treated cancers.
- Recent surgery, chemotherapy, radiotherapy, immunotherapy, investigational agents, or other anti-cancer therapy within 4 weeks (2 weeks for palliative radiotherapy).
- Tumor encasement of internal carotid artery or nasopharyngeal necrosis found on endoscopy.
- Significant bleeding events or visible hemoptysis recently.
- Active peptic ulcers or recent gastrointestinal surgery or serious GI conditions.
- Uncontrolled hypertension or serious heart conditions within 6 months.
- History of bleeding disorders or current use of anticoagulants/antiplatelets unless stopped 10 days prior and meets coagulation criteria.
- Severe infections requiring IV treatment recently or high fever.
- Known severe allergies to study drugs or excipients.
- Conditions affecting oral drug absorption.
- Recent use of immunosuppressants or high-dose corticosteroids.
- Active or history of autoimmune diseases likely to recur except some exceptions.
- Recent severe respiratory disease exacerbations or active tuberculosis.
- HIV positive or active hepatitis B or C infection.
- Receipt of live vaccines recently or planned during study.
- Positive pregnancy test or breastfeeding.
- Women of childbearing potential or sexually active men unwilling/unable to use contraception.
- Any condition that may interfere with study results or patient safety as determined by the investigator.
AI-Screening
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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
CONTACT
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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