Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Treatment

Metastatic Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05484375
• Other study ID #: IIT-2022-017(FL5)
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2022
• Est. completion date: September 2029

Study information

• Verified date: July 2022
• Source: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Contact: Yin Wen-Jing
• Phone: 0086-13929503157
• Email: wenjing1342[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2029
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Histology confirmed metastatic nasopharyngeal carcinoma following radical treatment(Stage IVb, AJCC/UICC 8th,any T,any N,M1)

2. Patients receiving gemcitabine/cisplatin in combination with terriprizumab received complete response (CR) or partial response (PR) after 4-6 cycles of imaging studies

3. Age =18 years and =65 years

4. WBC=4×10^9/L, platelet = 100×10^9/L, hemoglobin = 90g/L and Albumin=28 g/L

5. With normal liver function test (TBIL#ALT#AST = 2.5×uln) (patients with liver metastasis=5×uln)

6. With normal renal function test (creatinine = 1.5×uln or CCR = 60ml/min)

7. ECOG score is 0-1

8. At least one measurable lesion according to RECIST v 1.1 (prior to gemcitabine/cisplatin plus toripalimab)

9. Life expectancy is at least 12 weeks

10. Patients sign informed consent forms

Exclusion Criteria:

1. History of severe anaphylaxis to any component of capecitabine or toripalimab

2. Active or untreated central nervous system metastases

3. Patient with necrotic lesions and judged by the investigator to be at risk of excessive bleeding

4. Patients with poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. Patients with indwelled catheters are allowed to participate.

5. Patients with poorly controlled or symptomatic hypercalcemia

6. Pregnancy or lactation

7. 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.

8. Patients who have previously received allogeneic bone marrow transplants or solid organ transplants.

9. History of autoimmune diseases

10. 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.

11. Receive any active vaccine within 4 weeks prior to enrollment

12. Basic medical conditions that the investigator identified as likely to affect significantly drug administration and protocol adherence of the study

13. Active pneumonia

14. Active infections, including tuberculosis, hepatitis B, hepatitis C or HIV.

15. Presence of severe neurological or psychiatric disorders, including dementia and seizures.

16. Peripheral nerves which was graded as= 2 according to NCI-CTCAE

17. Major cardiovascular diseases

Related Conditions & MeSH terms

• Carcinoma
• Metastatic Nasopharyngeal Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• Capecitabine plus toripalimab
Capecitabine tablet: 650mg/m2, orally, twice a day, d1-d21, every 3 weeks Toripalimab: 240mg, intravenous drip, d1, every 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Affiliated Cancer Hospital & Institute of Guangzhou Medical University	Hunan Cancer Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival(PFS)	The time is defined from the enrolment to progression or death from any cause	up to 24 month
Secondary	overall survival(OS)	The time is defined from the enrolment to death from any cause	up to 24 month
Secondary	Objective Response Rate(ORR)	The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1	up to 24 month
Secondary	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	up to 24 month
Secondary	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	up to 24 month
Secondary	Adverse Events (AEs)	All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0	up to 24 month