Back to resultsCapecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Treatment
Primary Purpose
Metastatic Nasopharyngeal Carcinoma
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Capecitabine plus toripalimab
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Nasopharyngeal Carcinoma focused on measuring nasopharyngeal carcinoma, capecitabine, toripalimab, maintenance therapy
Eligibility Criteria
Inclusion Criteria:
- Histology confirmed metastatic nasopharyngeal carcinoma following radical treatment（Stage IVb, AJCC/UICC 8th，any T，any N，M1）
- Patients receiving gemcitabine/cisplatin in combination with terriprizumab received complete response (CR) or partial response (PR) after 4-6 cycles of imaging studies
- Age ≥18 years and ≤65 years
- WBC≥4×10^9/L, platelet ≥ 100×10^9/L, hemoglobin ≥ 90g/L and Albumin≥28 g/L
- With normal liver function test (TBIL#ALT#AST ≤ 2.5×uln) (patients with liver metastasis≤5×uln)
- With normal renal function test (creatinine ≤ 1.5×uln or CCR ≥ 60ml/min)
- ECOG score is 0-1
- At least one measurable lesion according to RECIST v 1.1 (prior to gemcitabine/cisplatin plus toripalimab)
- Life expectancy is at least 12 weeks
- Patients sign informed consent forms
Exclusion Criteria:
- History of severe anaphylaxis to any component of capecitabine or toripalimab
- Active or untreated central nervous system metastases
- Patient with necrotic lesions and judged by the investigator to be at risk of excessive bleeding
- Patients with poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. Patients with indwelled catheters are allowed to participate.
- Patients with poorly controlled or symptomatic hypercalcemia
- Pregnancy or lactation
- Malignancies other than nasopharyngeal carcinoma, with negligible risk of metastasis or death and radical outcome expected after treatment, within the 5 years prior to enrollment.
- Patients who have previously received allogeneic bone marrow transplants or solid organ transplants.
- History of autoimmune diseases
- Received systemic immunostimulant therapy (except toripalimab in palliative chemotherapy, including but not limited to interferon or IL-2) within 4 weeks prior to enrollment or during 5 half-lives of the drug.
- Receive any active vaccine within 4 weeks prior to enrollment
- Basic medical conditions that the investigator identified as likely to affect significantly drug administration and protocol adherence of the study
- Active pneumonia
- Active infections, including tuberculosis, hepatitis B, hepatitis C or HIV.
- Presence of severe neurological or psychiatric disorders, including dementia and seizures.
- Peripheral nerves which was graded as≥ 2 according to NCI-CTCAE
- Major cardiovascular diseases
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Capecitabine plus toripalimab maintenance therapy
Arm Description
capecitabine and toripalimab were used as maintenance therapy every 3 weeks until toxicity was unacceptable, disease progression, consent withdrawal, or withdrawal was determined by the investigator, or a maximum of 2 years of treatment had been reached.
Outcomes
Primary Outcome Measures
progression-free survival(PFS)
The time is defined from the enrolment to progression or death from any cause
Secondary Outcome Measures
overall survival(OS)
The time is defined from the enrolment to death from any cause
Objective Response Rate(ORR)
The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1
Disease Control Rate (DCR)
The proportion of patients who have achieved complete response，partial response and Stable disease assessed by investigators according to Recist v 1.1
Duration of Response (DoR)
The time is defined from first documented objective response to radiographic disease progression or death, whichever occurred first, assessed by investigator
Adverse Events (AEs)
All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0
Full Information
NCT ID
NCT05484375
First Posted
July 30, 2022
Last Updated
July 30, 2022
Sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Hunan Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05484375
Brief Title
Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Treatment
Official Title
Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Gemcitabine/Cisplatin Plus Toripalimab Treatment: a Single Arm, Open Label, Multicenter, Phase II Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
September 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Hunan Cancer 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
to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine/cisplatin combined with toripalimab.
Detailed Description
This study is to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine/cisplatin combined with toripalimab. Patients received a standard dose of toripalimab combined with gemcitabine/cisplatin every 3 weeks (Q3W) for 4-6 cycles. Efficacy was assessed after 4-6 courses of chemotherapy, and patients with PR/CR were enrolled in the clinical trial for maintenance therapy. During maintenance therapy, capecitabine and toripalimab were used as maintenance therapy every 3 weeks until toxicity was unacceptable, disease progression, consent withdrawal, or withdrawal was determined by the investigator, or a maximum of 2 years of treatment had been reached.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Nasopharyngeal Carcinoma
Keywords
nasopharyngeal carcinoma, capecitabine, toripalimab, maintenance therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Capecitabine plus toripalimab maintenance therapy
Arm Type
Experimental
Arm Description
capecitabine and toripalimab were used as maintenance therapy every 3 weeks until toxicity was unacceptable, disease progression, consent withdrawal, or withdrawal was determined by the investigator, or a maximum of 2 years of treatment had been reached.
Intervention Type
Drug
Intervention Name(s)
Capecitabine plus toripalimab
Intervention Description
Capecitabine tablet: 650mg/m2, orally, twice a day, d1-d21, every 3 weeks Toripalimab: 240mg, intravenous drip, d1, every 3 weeks
Primary Outcome Measure Information:
Title
progression-free survival(PFS)
Description
The time is defined from the enrolment to progression or death from any cause
Time Frame
up to 24 month
Secondary Outcome Measure Information:
Title
overall survival(OS)
Description
The time is defined from the enrolment to death from any cause
Time Frame
up to 24 month
Title
Objective Response Rate(ORR)
Description
The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1
Time Frame
up to 24 month
Title
Disease Control Rate (DCR)
Description
The proportion of patients who have achieved complete response，partial response and Stable disease assessed by investigators according to Recist v 1.1
Time Frame
up to 24 month
Title
Duration of Response (DoR)
Description
The time is defined from first documented objective response to radiographic disease progression or death, whichever occurred first, assessed by investigator
Time Frame
up to 24 month
Title
Adverse Events (AEs)
Description
All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0
Time Frame
up to 24 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histology confirmed metastatic nasopharyngeal carcinoma following radical treatment（Stage IVb, AJCC/UICC 8th，any T，any N，M1）
Patients receiving gemcitabine/cisplatin in combination with terriprizumab received complete response (CR) or partial response (PR) after 4-6 cycles of imaging studies
Age ≥18 years and ≤65 years
WBC≥4×10^9/L, platelet ≥ 100×10^9/L, hemoglobin ≥ 90g/L and Albumin≥28 g/L
With normal liver function test (TBIL#ALT#AST ≤ 2.5×uln) (patients with liver metastasis≤5×uln)
With normal renal function test (creatinine ≤ 1.5×uln or CCR ≥ 60ml/min)
ECOG score is 0-1
At least one measurable lesion according to RECIST v 1.1 (prior to gemcitabine/cisplatin plus toripalimab)
Life expectancy is at least 12 weeks
Patients sign informed consent forms
Exclusion Criteria:
History of severe anaphylaxis to any component of capecitabine or toripalimab
Active or untreated central nervous system metastases
Patient with necrotic lesions and judged by the investigator to be at risk of excessive bleeding
Patients with poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. Patients with indwelled catheters are allowed to participate.
Patients with poorly controlled or symptomatic hypercalcemia
Pregnancy or lactation
Malignancies other than nasopharyngeal carcinoma, with negligible risk of metastasis or death and radical outcome expected after treatment, within the 5 years prior to enrollment.
Patients who have previously received allogeneic bone marrow transplants or solid organ transplants.
History of autoimmune diseases
Received systemic immunostimulant therapy (except toripalimab in palliative chemotherapy, including but not limited to interferon or IL-2) within 4 weeks prior to enrollment or during 5 half-lives of the drug.
Receive any active vaccine within 4 weeks prior to enrollment
Basic medical conditions that the investigator identified as likely to affect significantly drug administration and protocol adherence of the study
Active pneumonia
Active infections, including tuberculosis, hepatitis B, hepatitis C or HIV.
Presence of severe neurological or psychiatric disorders, including dementia and seizures.
Peripheral nerves which was graded as≥ 2 according to NCI-CTCAE
Major cardiovascular diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yin Wen-Jing
Phone
0086-13929503157
Email
wenjing1342@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Jin-Quan
Phone
0086-137-1086-6485
Email
609149209@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yin Wen-Jing
Organizational Affiliation
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Treatment
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