The First Affiliated Hospital of Xiamen University
Phase
Phase 2
Started
2024-11-13
Last updated
2025-08-07
Condition(s) studied
Nasopharyngeal NeoplasmsElderlyChemotherapy
Investigational drug(s) / intervention(s)
IMRT combined with lobaplatin-based concurrent chemotherapy
IMRT combined with lobaplatin-based concurrent chemotherapy: IMRT combined with two cycles of lobaplatin-based concurrent chemotherapy
Study summary
This prospective, multicenter, single-arm, open-label phase II clinical study aimed to investigate the efficacy and safety of intensity-modulated radiotherapy combined with lobaplatin-based concurrent chemotherapy in the treatment of elderly patients with nasopharyngeal carcinoma
Eligibility
Sex
ALL
Min age
65 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Pathologically confirmed differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma;
* Stage II-IVa (UICC 8th edition);
* Acceptable induction chemotherapy and Tarceva targeted therapy;
* No history of other malignant tumors;
* Male or female, aged 65-80 years.
* Liver function: Total bilirubin ≤ Upper Limit of Normal (ULN); AST and ALT ≤ 2.5 times ULN; Alkaline phosphatase ≤ 5 times ULN;
* Renal function: Creatinine clearance ≥ 60 ml/min or Creatinine ≤ 1.5 × ULN;
* Hematological tests: Absolute Neutrophil Count (ANC) ≥ 2 × 10\^9/L, Platelet count ≥ 100 × 10\^9/L, and Hemoglobin ≥ 9 g/dL;
* No severe dysfunction of vital organs such as heart and lung;
* PS score ≤ 2 points
Exclusion Criteria:
* Distant metastases detected before treatment;
* Refusal to sign the informed consent form;
* Patients who cannot comply with regular follow-up due to psychological, social, family, or geographical reasons;
* Simultaneously receiving other experimental treatments in clinical trials (during the treatment phase of clinical research);
* Severe, uncontrolled infections or medical conditions;
* Vital organ dysfunction, decompensated heart, lung, kidney, or liver failure, unable to tolerate radiotherapy and chemotherapy;
* Laboratory tests: Total bilirubin \> Upper Limit of Normal (ULN); AST and/or ALT \> 1.5 times ULN with alkaline phosphatase \> 2.5 times ULN;
* Factors affecting drug administration, distribution, metabolism, and excretion, such as mental abnormalities, central nervous system abnormalities, chronic diarrhea, ascites, pleural effusion, etc.;
* Long-term use of immunosuppressants after organ transplantation;
* Patients with a history of other malignant tumors before enrollment.
Primary outcome measure(s)
objective response rate (ORR) — 6 months ORR encompasses both CR and PR.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Xiamen University
Xiamen
Fujian
More The First Affiliated Hospital of Xiamen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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