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Radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma resistant to induction chemotherapy: A phase II trial

Radiotherapy combined with recombinant human endostatin and capecitabine in the treatment of nasopharyngeal carcinoma with stable or progressive disease after induction chemotherapy: A phase II trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081969
Enrollment
Unknown
Registered
2024-03-18
Start date
2023-04-18
Completion date
Unknown
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nasopharyngeal carcinoma

Interventions

experimental group:Patients received radiotherapy Combined With Endostatin and Capecitabine

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: a. The pathological type is non keratinizing carcinoma. b. The staging is T3-4N1/N2-3. c. There is no evidence of distant metastasis (M0). d. Functional status: KPS>70. e. Normal bone marrow function: white blood cell count>4 × 109/L, hemoglobin>90g/L, and platelet count>100 × 109/L. f. Normal liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST)60 ml/min h. The patient must be informed of the basic content of this study and sign an informed consent form. I. The efficacy evaluation after 2 cycles of neoadjuvant chemotherapy is SD or PD.

Exclusion criteria

Exclusion criteria: a. The pathological type is keratinizing squamous cell carcinoma or basal squamous cell carcinoma of WHO. b. Age>65 years old or<18 years old. c. The treatment is palliative. d. Has a history of malignant tumors in the past. Excluding fully treated basal cell carcinoma, squamous cell carcinoma, and cervical carcinoma in situ. e. Pregnant or lactating women (consider pregnancy testing for women of reproductive age; emphasize effective contraception during treatment). f. Previously received radiation therapy (excluding skin cancer that is not melanoma and the previous lesion is located outside the target area of radiation therapy). g. The primary lesion and cervical metastatic lesion have received chemotherapy or surgical treatment (excluding diagnostic treatment). h. Accompanied by other serious illnesses, it may bring significant risks or affect the compliance of the trial.

Design outcomes

Primary

MeasureTime frame
Three-year Recurrence free survival (RFS);

Secondary

MeasureTime frame
Overall Survival (OS);three-year locoregional recurrence free survival (LRRFS) rate;Three-year distant metastasis-free survival (DMFS) rate;safety;Quality of life;

Countries

China

Contacts

Public ContactTing Jin

Zhejiang Cancer Hospital

jinting@zjcc.org.cn+86 571 8812 8202

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026