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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05807880
Other study ID # ALTER-HN005
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date October 1, 2023
Est. completion date October 1, 2025

Study information

Verified date September 2023
Source Sun Yat-sen University
Contact Jun Ma, M.D.
Phone +862087343469
Email majun@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

First-diagnosed metastasis or recurrence/metastasis NPC Patients will be treated with anlotinib, penpulimab and capecitabine.


Description:

The trial is an open-label, single-arm, phase II clinical trial. This trial plans to enroll patient that is diagnosed with locoregionally advanced nasopharyngeal carcinoma at his/her first diagnosis, and has recurrence/metastasis at least 6 months after completing radiotherapy and chemotherapy for the primary lesion, and has never accepted systemic treatment for recurrent/metastatic lesion before. The first-line treatment is the three-drug treatment plan, including anlotinib, penpulimab and capecitabine, for 4-6 cycles. Then a maintenance treatment will be run, including penpulimab and capecitabine, until PD or intolerance to toxicity.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
The combination treatment of anlotinib, penpulimab and capecitabine.
Patients will receive the combination treatment of anlotinib, penpulimab and capecitabine every three weeks until PD or intolerance to drug toxicity. For each cycle, patients receive anlotinib 10mg, po, qd from day 1 to day 14, penpulimab 200mg, iv in day 1, and capecitabine 650mg/m2, po, bid.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Sun Yat-sen University Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

References & Publications (10)

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Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival (PFS) Progression-free survival is measured according to the RECIST 1.1. 3-year
Secondary Objective remission rate (ORR) Objective remission rate is measured according to the RECIST 1.1. Median value
Secondary Progression-free survival (PFS) Progression-free survival is measured according to the iRECIST. 3-year
Secondary Overall survival (OS) Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive. 3-year
Secondary Quality of Life (QoL) Quality of Life is measured by the Quality of Life Questionnaire-Core 30 module (QLQ-C30) designed by European Organisation for Research and Treatment of Cancer (EORTC). 3-year
Secondary Quality of Life (QoL) Quality of Life is measured by the FACT-H&N designed by The Center on Outcomes Research and Education. 3-year
Secondary Incidence of toxicities Incidence of toxicities are measured by questionnaires covering adverse effect (AE), severe adverse effect (SAE), treatment-related adverse effect (TRAE), treatment-related severe adverse effect (TRSAE), immune-related adverse effect, immune-related treatment-related adverse effect according to NCI-CTC AE V5.0. 3-year
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