Standard chemoradiotherapy with concurrent and adjuvant camrelizumab in patients with high risk nasopharyngeal carcinoma: multicentre, randomised, open label, phase 3 trial.
Rui You, Gui-Qiong Xu, Xi Ding...
https://pubmed.ncbi.nlm.nih.gov/41667193Actively Recruiting
Phase 3
Age: 18Years - 70Years
All Genders
ID04453826
A Multicenter Randomized Clinical Trial of Induction Chemotherapy Plus Concurrent Chemo-radiotherapy With or Without Camrelizumab for High Risk Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2020-09-28
388
Participants Needed
6
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
A
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the addition of PD-1 treatment to chemo-radiotherapy for high-risk patients with nasopharyngeal carcinoma. This study is a multicenter, open-label, randomized clinical trial comparing outcomes between patients receiving combined PD-1 therapy with chemo-radiotherapy and those receiving chemo-radiotherapy alone. The goal is to see if the combined approach can reduce disease progression and improve survival. Participants are randomly assigned to one of two groups. One group receives three cycles of gemcitabine and cisplatin induction chemotherapy followed by concurrent chemo-radiotherapy with camrelizumab given intravenously during radiotherapy and continued for one year after. The other group receives the same chemotherapy and chemo-radiotherapy without camrelizumab. Radiotherapy is delivered using specific dosing schedules across several target volumes. During the study, participants undergo regular assessments including monitoring for disease progression, survival, treatment-related complications, and quality of life using standardized questionnaires. The primary outcome measured is progression-free survival over three years, with secondary outcomes including overall survival, metastasis-free survival, relapse-free survival, and treatment safety. The total study period extends up to three years for follow-up and evaluation.
CONDITIONS
Brief Title
Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III)
- Staged as T4N0-2M0,T1-4N3M0 (stage IVa) or T1-3N1-2M0, T2-3N0M0 (stage II-III) with specific disease status after induction chemotherapy
- Aged between 18 and 70 years
- Karnofsky performance score of 70 or above
- Normal bone marrow function
- Normal liver and kidney function within specified limits
- Provided written informed consent
You will not qualify if you...
- Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma
- Recurrent or metastatic nasopharyngeal carcinoma
- Disease showing partial or complete response and EBV DNA of 0 copies/mL after induction chemotherapy
- Known allergy to study therapy components
- Presence of other malignant tumors
- Active or history of autoimmune disease
- History of psychiatric substance abuse, alcoholism, or drug addiction
- Laboratory values not meeting study standards within 7 days before enrollment
- Recent use of systemic glucocorticoids within 4 weeks
- Active or recent tuberculosis infection
- Prior therapy with PD-1, PD-L1, or CTLA-4 agents
- Active autoimmune diseases requiring systemic treatment (except certain skin diseases)
- Known HIV infection
- Positive hepatitis B or C with high viral load
- Received live vaccine within 4 weeks before study
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Induction Chemotherapy
Duration - Approximately 9 weeks
Participants receive 3 cycles of gemcitabine plus cisplatin chemotherapy before starting chemo-radiotherapy.
3 chemotherapy cycles, 1 cycle every 3 weeks
Concurrent Chemo-radiotherapy
Duration - Approximately 6 to 7 weeks
Participants undergo concurrent chemo-radiotherapy with cisplatin chemotherapy and intensity-modulated radiotherapy (IMRT). Participants in the experimental arm also receive camrelizumab during this period.
Concurrent chemotherapy cycles and daily radiotherapy sessions over 33 fractions; 2 cycles of camrelizumab for experimental arm
Adjuvant Camrelizumab Treatment
Duration - Up to 1 year
Participants in the experimental arm receive camrelizumab treatment for up to 1 year after the end of radiotherapy to maintain immune response.
Camrelizumab administered every 3 weeks
Follow-up
Duration - Up to 3 years
Participants are monitored for treatment outcomes and safety, including progression-free survival and survival quality assessments.
Regular follow-up visits as per study schedule
Trial Site Locations
Total: 6 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China, 510095
Not Yet Recruiting
3
Yuebei People's Hospital
Shaoguan, Guangdong, China, 512025
Not Yet Recruiting
4
Zhongshan People's Hospital
Zhongshan, Guangdong, China, 528403
Actively Recruiting
5
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China, 519000
Actively Recruiting
6
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China, 543002
Not Yet Recruiting
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Research Team
M
Ming-Yuan Chen, MD, PhD
R
Rui You, MD, PhD
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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