Clinical trial · Interventional
Neoadjuvant Chemotherapy and Low-dose Radiotherapy Sequential Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Nasopharyngeal carcinoma（NPC）is common malignant tumor in China. The incidence of NPC in most parts of the world and the country is less than 1/10 million, but the incidence rate in China's Guangdong, Guangxi, Fujian and other southern provinces is as high as 33/10 million. Generally, there are more men than women, with a ratio of 2 \~ 3:1. In high incidence area, nasopharyngeal carcinoma has great harm to middle-aged and young people, and incidence rate and mortality rate increase significantly after 30 years old. 50\~60 years old is the highest peak. More than 70% of patients were in advanced stage at the first diagnosis. At present, the main treatment for locally advanced nasopharyngeal carcinoma is platinum based neoadjuvant chemotherapy combined with concurrent chemoradiotherapy. However, recurrence and distant metastasis after standard treatment are the main causes of failure. About 40% of patients with locally advanced nasopharyngeal carcinoma have recurrence and distant metastasis after receiving standard treatment. Therefore, the investigators intend to further explore the improvement of local control and survival rate of locally advanced nasopharyngeal carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| low-dose radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- low-dose radiotherapy group
- description
- Neoadjuvant chemotherapy combined with low-dose radiotherapy sequential concurrent chemoradiotherapy
- interventionNames
- Radiation: low-dose radiotherapy
- type
- NO_INTERVENTION
- label
- control group
- description
- Neoadjuvant chemotherapy sequential concurrent chemoradiotherapy
Primary outcomes (1)
- measure
- The objective remission rate
- timeFrame
- assessed 3 weeks after the induction treatment
- description
- Efficacy evaluation .The main indicator is objective remission rate (ORR=CR+PR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntarily participate and sign the informed consent form of the study in writing 2. Age 18-70 years old, regardless of gender 3. Pathological biopsy confirmed nasopharyngeal squamous cell carcinoma 4. Initial treatment 5. There are lesions that can be measured according to RECIST standard 6. KPS score ≥ 80 7. Estimated survival ≥ 6 months 8. The urine pregnancy test was negative (female), and contraceptive measures were taken from the test period to 3 months after the end of the test 9. Sufficient hematopoietic function: WBC ≥ 4 × 109/L，Hb≥100g/L，PLT≥100 × 109/L 10. Liver function: ALAT / ASAT \< 1.5 times of ULN, bilirubin \< 1.5 × ULN 11. Renal function: serum creatinine \< 1.5 × ULN 12. No distant metastasis 13. Lymph nodes meet one of them:node necrosis, extranodal invasion, or shortest diameter ≥3 cm 14. The clinical stage was N2-3 (AJCC / UICC 8th Edition) locally advanced nasopharyngeal carcinoma 15. According to the judgment of the researcher, the patient is considered to be able to comply with the protocol. Exclusion Criteria: 1. There is evidence of distant metastasis 2. The primary tumor or lymph node has been treated surgically (except biopsy) 3. Patients with primary focus or lymph nodes who have received radiotherapy 4. Those who have received epidermal growth factor targeted therapy 5. The primary focus has received chemotherapy or immunotherapy 6. Other malignant tumors (except non melanoma skin cancer or cervical carcinoma in situ) 7. Subjects who have received other drug trials in recent 1 month 8. Pregnant or lactating women and women of childbearing age who refuse contraception during the treatment observation period 9. Have a serious history of allergy or special constitution 10. A history of severe lung or heart disease or serious complications, such as uncontrollable hypertension and heart failure 11. Refusal or inability to sign informed consent to participate in the trial 12. Drug or alcohol addicts 13. Having personality or mental illness, no civil capacity or limited civil capacity 14. Creatinine clearance \< 30ml / min 15. Active systemic infection 16. At the same time, they received chronic systemic immunotherapy or hormone therapy other than this study.
References
Publications (0)
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