Actively Recruiting
Gemcitabine and Camrelizumab Plus Apatinib Versus Cisplatin in First-line Treatment of RM-NPC
Led by Sun Yat-sen University · Updated on 2023-05-11
244
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to explore a new, more effective and tolerable treatment regimen for patients with advanced recurrent/metastatic nasopharyngeal carcinoma. Specifically, we plan to conduct a phase III randomized controlled clinical trial based on the standard treatment of "GP + PD-1 mAb", replacing cisplatin with apatinib to achieve "platinum-free" therapy and reduce toxicity. In addition, we will investigate the efficacy of using apatinib in combination with PD-1 mAb compared to PD-1 mAb monotherapy to further improve treatment outcomes. The ultimate goal is to provide a new and reliable treatment modality for patients with advanced recurrent/metastatic nasopharyngeal carcinoma and guide clinical practice.
CONDITIONS
Official Title
Gemcitabine and Camrelizumab Plus Apatinib Versus Cisplatin in First-line Treatment of RM-NPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 70 years
- Histopathologically confirmed nonkeratinizing recurrent or metastatic nasopharyngeal carcinoma
- No prior systemic treatment for recurrent or metastatic lesions
- Completed any prior radiotherapy or chemotherapy at least 6 months before enrollment
- ECOG performance status of 0 or 1
- At least one measurable lesion by RECIST v1.1 criteria
- Adequate organ function based on lab tests
- Life expectancy greater than 12 weeks
- Able to understand and sign informed consent form
You will not qualify if you...
- High risk of nasopharyngeal necrosis due to recent or repeated radiotherapy
- Other malignancies except certain treated cancers (cervical, skin, prostate, ductal carcinoma in situ)
- Active bleeding, ulcers, bowel perforations, recent major surgery within 30 days, or tumors near major vessels at risk of bleeding
- Uncontrolled hypertension or significant heart disease including arrhythmia and cardiac insufficiency
- Known or suspected autoimmune diseases including dementia and seizures
- Conditions affecting oral medication absorption
- Recent high-dose glucocorticoids use within 4 weeks
- Need for long-term immunosuppressive or corticosteroid therapy
- HIV positive, active hepatitis B or C infection
- Positive pregnancy test or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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