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Maintenance Therapy With Treprilimumab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma, Maintenance Therapy

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Capecitabine/Placebo combined with treprizumab
Sponsored by
XIANG YANQUN
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The age at the time of diagnosis is 18-75 years old, regardless of gender; Histologically confirmed nasopharyngeal carcinoma; Confirm the presence of distant metastasis in advanced nasopharyngeal carcinoma patients or recurrent nasopharyngeal carcinoma patients who cannot receive local treatment. ; After receiving standard treatment for 4-6 cycles, the disease is control; ECOG score 0-1; Expected survival time of at least 12 weeks; Patients who have not received systemic chemotherapy within 6 months prior to diagnosis ; According to RECIST 1.1 standard, at least 1 measurable lesion; Enough organ function; Sign an informed consent form; Female participants with fertility and male participants with fertility partners must agree to use reliable contraceptive measures within 6 months after screening and the last treatment. Exclusion Criteria: Patients who are known to be intolerant to capecitabine or allergic to any therapeutic drug, or who are participating in clinical studies of other new drugs; Diseases that may interfere with oral medication treatment, including but not limited to swallowing difficulties, chronic diarrhea, or intestinal obstruction; Previous or current history of other tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, and thyroid papillary carcinoma; Sever heart disease; Central nervous system metastasis with clinical symptoms; Serious infections ; Within 4 weeks of signing the informed consent form, receive systemic hormone or other immunosuppressive therapy with an equivalent dose greater than 10mg prednisone per day. Subjects with a systemic hormone dose ≤ 10mg prednisone per day or inhaled/topical corticosteroids can be enrolled in the study; Patients with active chronic hepatitis B or active hepatitis C. A history of interstitial pneumonia or other autoimmune diseases. HIV infection; Individuals with significant organ dysfunction or uncontrollable comorbidities, including but not limited to uncontrollable hypertension, decompensated liver cirrhosis, active peptic ulcer, or hemorrhagic disease; Less than 6 weeks after major organ surgery; Pregnant or breast feeding; Patients with mental illness, those with a history of alcohol or drug abuse, or those who are unable to obtain informed consent; Other researchers have determined that it is not suitable to participate in this trial. Those who refuse or are unable to sign the informed consent form.

Sites / Locations

  • SunYat-senURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Capecitabine combined with treprizumab maintenance group

Placebo combined with teriprizumab maintenance group

Arm Description

Capecitabine, 1000 mg/m2/dose, twice a day, days 1-14; 21 days/cycle Treprizumab, 240mg, intravenously, day 1 and 21 days/cycle

Placebo, 1000 mg/m2/dose, twice a day, days 1-14; 21 days/cycle Treprizumab, 240mg, intravenously, day 1 and 21 days/cycle

Outcomes

Primary Outcome Measures

Progression free survival
Progression free survival is defined as the time interval between randomization and the first recording of tumor progression (evaluated according to RECIST 1.1 criteria, regardless of continued treatment) or death from any cause

Secondary Outcome Measures

Full Information

First Posted
May 11, 2023
Last Updated
May 11, 2023
Sponsor
XIANG YANQUN
Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Zhujiang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05869227
Brief Title
Maintenance Therapy With Treprilimumab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal Carcinoma
Official Title
The Efficacy and Safety of Maintenance Therapy With Treprilimumab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal Carcinoma:Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2023 (Actual)
Primary Completion Date
April 28, 2026 (Anticipated)
Study Completion Date
April 28, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
XIANG YANQUN
Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Zhujiang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to investigate the efficacy and safety of the "capecitabine combined with trepril monoclonal antibody maintenance regimen" in improving the first-line treatment of recurrent and metastatic nasopharyngeal carcinoma after receiving remission through chemotherapy combined with anti PD-1 monoclonal antibody standard regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma, Maintenance Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Capecitabine combined with treprizumab maintenance group
Arm Type
Experimental
Arm Description
Capecitabine, 1000 mg/m2/dose, twice a day, days 1-14; 21 days/cycle Treprizumab, 240mg, intravenously, day 1 and 21 days/cycle
Arm Title
Placebo combined with teriprizumab maintenance group
Arm Type
Placebo Comparator
Arm Description
Placebo, 1000 mg/m2/dose, twice a day, days 1-14; 21 days/cycle Treprizumab, 240mg, intravenously, day 1 and 21 days/cycle
Intervention Type
Drug
Intervention Name(s)
Capecitabine/Placebo combined with treprizumab
Intervention Description
Combined
Primary Outcome Measure Information:
Title
Progression free survival
Description
Progression free survival is defined as the time interval between randomization and the first recording of tumor progression (evaluated according to RECIST 1.1 criteria, regardless of continued treatment) or death from any cause
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The age at the time of diagnosis is 18-75 years old, regardless of gender; Histologically confirmed nasopharyngeal carcinoma; Confirm the presence of distant metastasis in advanced nasopharyngeal carcinoma patients or recurrent nasopharyngeal carcinoma patients who cannot receive local treatment. ; After receiving standard treatment for 4-6 cycles, the disease is control; ECOG score 0-1; Expected survival time of at least 12 weeks; Patients who have not received systemic chemotherapy within 6 months prior to diagnosis ; According to RECIST 1.1 standard, at least 1 measurable lesion; Enough organ function; Sign an informed consent form; Female participants with fertility and male participants with fertility partners must agree to use reliable contraceptive measures within 6 months after screening and the last treatment. Exclusion Criteria: Patients who are known to be intolerant to capecitabine or allergic to any therapeutic drug, or who are participating in clinical studies of other new drugs; Diseases that may interfere with oral medication treatment, including but not limited to swallowing difficulties, chronic diarrhea, or intestinal obstruction; Previous or current history of other tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, and thyroid papillary carcinoma; Sever heart disease; Central nervous system metastasis with clinical symptoms; Serious infections ; Within 4 weeks of signing the informed consent form, receive systemic hormone or other immunosuppressive therapy with an equivalent dose greater than 10mg prednisone per day. Subjects with a systemic hormone dose ≤ 10mg prednisone per day or inhaled/topical corticosteroids can be enrolled in the study; Patients with active chronic hepatitis B or active hepatitis C. A history of interstitial pneumonia or other autoimmune diseases. HIV infection; Individuals with significant organ dysfunction or uncontrollable comorbidities, including but not limited to uncontrollable hypertension, decompensated liver cirrhosis, active peptic ulcer, or hemorrhagic disease; Less than 6 weeks after major organ surgery; Pregnant or breast feeding; Patients with mental illness, those with a history of alcohol or drug abuse, or those who are unable to obtain informed consent; Other researchers have determined that it is not suitable to participate in this trial. Those who refuse or are unable to sign the informed consent form.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanqun Xiang
Phone
18666096623
Email
xiangyq@syscc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Guoying Liu
Phone
18127919832
Email
liugy0109@163.com
Facility Information:
Facility Name
SunYat-senU
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanqun Xiang, MD
Phone
+86-18666096623
Email
xiangyq@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Weixiong Xia, MD
Phone
+86-18520415699
Email
xiawx@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Maintenance Therapy With Treprilimumab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal Carcinoma

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