Trials Sponsors Conditions Drugs Pricing

Conditions

Nasopharyngeal Carcinoma TNF Chemo-radiotherapy

Outcome Measures

Primary Outcomes (3)

OS
Overall survival Overall survival Overall survival Overall survival Overall survival Overall survival Overall survival Overall survival
Up to 5 years
PFS
Progression-free survival
Up to 5 years
Severe drug-related adverse events
grade III-V according to CTCAE v4.0
Up to 2 approximately years

Secondary Outcomes (4)

ORR
Up to 2 approximately years
DCR
Up to 2 approximately years
DOR
Up to 2 approximately years
Drug-related adverse events grade I-II
Up to 2 approximately years

Study Arms (2)

Control group

PLACEBO COMPARATOR

Chemotherapy: 5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle; Cisplatin: 80mg/m2, used on the 1st and 28th day of each cycle; Q60d; Every 2 months for a treatment cycle, use 2 cycles, a total of 4 months. Radiotherapy: Radiotherapy was initiated on day 15 of the first cycle of chemotherapy GTV: 6810cGy (227 cGy/30f) Or 6996 cGy (212 cGy/ 33F); CTV: 5400-6000 cGy (180-200 cGy/f); Radiotherapy once a day, 5 times a week, a total of 30-33 times, a total of about 6 weeks. Placebo: Normal saline 1-2ml, intramuscular injection, QD, 30 days in the first and third months, once a day.

Drug: 5-fuDrug: CisplatinRadiation: RadiotherapyDrug: Placebo

Experimental group

ACTIVE COMPARATOR

Chemotherapy: 5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle; Cisplatin: 80mg/m2, used on the 1st and 28th day of each cycle; Q60d; Every 2 months for a treatment cycle, use 2 cycles, a total of 4 months. Radiotherapy: Radiotherapy was initiated on day 15 of the first cycle of chemotherapy GTV: 6810cGy (227 cGy/30f) Or 6996 cGy (212 cGy/ 33F); CTV: 5400-6000 cGy (180-200 cGy/f); Radiotherapy once a day, 5 times a week, a total of 30-33 times, a total of about 6 weeks. Tianenfu (recombinant human tumor necrosis factor for injection) : 1 million IU (BSA\<2.0m2) or 1.5 million IU (BSA≥2.0m2), dissolved in normal saline 1-2mL, intrascularization, QD, 30 days in the first and third months, once a day.

Interventions

5-fuDrug

5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle.

Control groupExperimental group

CisplatinDrug

Cisplatin: 80mg/m2, used on the 1st and 28th day of each cycle.

Control group

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

≥18 years old and ≤60 years old;
Pathologically confirmed nasopharyngeal carcinoma;

Sponsors & Collaborators

Shanghai Weike Bioscience Co., Ltd.
Type not reportedcollaborator
Sun Yat-sen University
Otherlead

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

FluorouracilCisplatinRadiotherapy

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal Diseases

Study Officials

Yun-fei Xia, MD
Sun Yat-sen University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun-fei Xia, MD

CONTACT

+8613602805461 xiayf@sysucc.org.cn

Study Design

Study Type: interventional
Phase: phase 2 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

June 22, 2022

First Posted

June 27, 2022

Study Start

July 1, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

You may not qualify if:

Have a history of allergy to 5-FU, cisplatin and tumor necrosis factor;
Previous treatment related to tumor necrosis factor (TNF);
Major surgery other than nasopharyngeal cancer was diagnosed within 28 days prior to randomization or major surgery was expected during the study period;
The subject has any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); Subjects with vitiligo or asthma in complete remission during childhood without any intervention as adults could be included; Subjects with asthma requiring medical intervention with bronchodilators were excluded);
Subject is taking immunosuppressants, or systemic, or absorbable sites Hormone therapy to achieve immunosuppression (dose \>10mg/ day prednisone or Other equally effective hormones) and continued to be used within 2 weeks prior to enrollment.
The subject has previous or co-existing malignancies (except those that have been cured and survived for more than 5 years without cancer, such as basal cell carcinoma of the skin, carcinoma in situ of the cervix and papillary carcinoma of the thyroid);
Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: ① HEART failure of NYHA grade 2 or above ② unstable angina pectoris ③ myocardial infarction within 1 year ⑤ clinically significant ventricular arrhythmias or ventricular arrhythmias requiring treatment or intervention;
Subjects have active infection or have unexplained fever \>38.5 degrees during screening but before the first dose (the investigator judged that the subjects' fever due to tumor could be included in the study);
Subjects with congenital or acquired immune deficiency (e.g. HIV infected), or active hepatitis (reference: HBsAg, anti-HBS, HBeAg, anti-HBC, anti-HBE, HBV DNA≥10⁴/ml, liver cell transaminase, etc.); Hepatitis C reference: HCV antibodies and HCVRNA);
The subject has a known history of psychotropic drug abuse, alcoholism or drug abuse;
In the judgment of the researcher, the subject has other factors that may lead to the termination of the study, such as other serious diseases (including mental diseases) requiring combined treatment, serious abnormal laboratory examination, family or social factors, which may affect the safety of the subject, or the collection of test data and samples.
Women who are pregnant or breastfeeding, or who refuse/cannot accept medically acceptable conditions. For women with potential pregnancy and sexually active men.

A Two-blinded, Multicentre, Phase II/III RCT of Concurrent Chemo-radiotherapy Combined or Not Combined With TNF as the Therapy for LA-NPC

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (2)

Control group

Experimental group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (2)

Control group

Experimental group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record