Radiotherapy Combined With Endostatin and Capecitabine for NPC

NCT05514275 | Recruiting Phase 2

• 1 other identifier: RCECNPC
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 7

Brief Summary

Radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma; Radiotherapy; Endostatin; Capecitabine

Outcome Measures

Primary Outcomes (1)

• Recurrence free survival (RFS)

  calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first

  3 years

Secondary Outcomes (5)

• overall survival (OS)

  5 years

• distant metastasis-free survival (DMFS)

  3 years

• Local-regional free survival (LRFS)

  3 years

• adverse events (AEs) and severe adverse events (SAE)

  5 years

• quality of life (QoL)

  3 years

Study Arms (1)

Endostatin and Capecitabine

EXPERIMENTAL

Patients received radiotherapy Combined With Endostatin and Capecitabine

Drug: Endostatin and Capecitabine

Interventions

Endostatin and Capecitabine DRUG

Patients received radiotherapy Combined With Endostatin(37.5mg/m2, continuous intravenous infusion for 120h, D-7, D8, D22, D36) and Capecitabine( 650 mg/m2 bid, orally, d1-21, every 3 weeks as a cycle for 17 cycles)

Endostatin and Capecitabine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
• Tumor staged as T3-4N1/N2-3 (according to the 8th American Joint Commission on Cancer edition).
• No evidence of distant metastasis (M0). Satisfactory performance status: Karnofsky scale (KPS) \> 70. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
• Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
• Adequate renal function: creatinine clearance ≥60 ml/min. Patients must be informed of the investigational nature of this study and give written informed consent.
• unsatisfactory tumor response (stable or progressive disease) after neoadjuvant chemotherapy (NACT)

You may not qualify if:

• WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
• Treatment with palliative intent. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
• Pregnancy or lactation. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
• Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
• satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (7)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

the First Hospital of Jiaxing

Jiaxing, Zhejiang, 314000, China

RECRUITING

Jinhua Central Hospital

Jinhua, Zhejiang, 321000, China

RECRUITING

The Central Hospital of Lishui City

Lishui, Zhejiang, 323000, China

RECRUITING

Ningbo First Hospital

Ningbo, Zhejiang, 315000, China

RECRUITING

Ningbo Medical Center Lihuili Eastern Hospital

Ningbo, Zhejiang, 315000, China

RECRUITING

People's Hospital of Quzhou

Quzhou, Zhejiang, 324000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Endostatins; Capecitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Ting Jin, MD

  Department of Radiation Oncology, Zhejiang Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Ting Jin, MD

CONTACT

+86-571-88128202; jinting@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Radiotherapy Combined With Endostatin and Capecitabine

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: August 24, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 24, 2022

Record last verified: 2022-08

Locations

CN (7)