Radiotherapy Combined With Endostatin and Capecitabine for NPC

NCT ID: NCT05514275

Last Updated: 2022-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2028-08-01

Brief Summary

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

Detailed Description

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This study was a single-arm, open-label, phase II study of radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy. fourty-one patients of locally advanced NPC resistant to induction chemotherapy were enrolled. Patients received radiotherapy combined with recombinant human endostatin and capecitabine. The primary endpoint was Recurrence free survival (RFS). Secondary goals included overall survival (OS), distant metastasis-free survival (DMFS), Local-regional free survival (LRFS); adverse events (AEs) and severe adverse events (SAE); safety and quality of life (QoL).

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Radiotherapy Combined With Endostatin and Capecitabine
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endostatin and Capecitabine

Patients received radiotherapy Combined With Endostatin and Capecitabine

Group Type EXPERIMENTAL

Endostatin and Capecitabine

Intervention Type 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)

Interventions

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Endostatin and Capecitabine

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)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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)

Exclusion Criteria

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin Ting

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ting Jin, MD

Role: STUDY_CHAIR

Department of Radiation Oncology, Zhejiang Cancer Hospital

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

the First Hospital of Jiaxing

Jiaxing, Zhejiang, China

Site Status RECRUITING

Jinhua Central Hospital

Jinhua, Zhejiang, China

Site Status RECRUITING

The Central Hospital of Lishui City

Lishui, Zhejiang, China

Site Status RECRUITING

Ningbo First Hospital

Ningbo, Zhejiang, China

Site Status RECRUITING

Ningbo Medical Center Lihuili Eastern Hospital

Ningbo, Zhejiang, China

Site Status RECRUITING

People's Hospital of Quzhou

Quzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ting Jin, MD

Role: CONTACT

+86-571-88128202

Facility Contacts

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Ting Jin, MD

Role: primary

+86-571-88128202

Binbin Song

Role: primary

Shubo Ding

Role: primary

Zhifeng Tian, MD

Role: primary

Pengrong Lou

Role: primary

Yi Lu

Role: primary

Zheng Peng

Role: primary

Other Identifiers

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RCECNPC

Identifier Type: -

Identifier Source: org_study_id

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