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Anlotinib, Penpulimab and Capecitabine in Recurrent/Metastatic Nasopharyngeal Carcinoma (ALTER-HN005)

Primary Purpose

Nasopharyngeal Neoplasms

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
The combination treatment of anlotinib, penpulimab and capecitabine.
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Neoplasms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants will be included only when they meet all inclusion criteria. Between 18 to 65 years old. ECOG PS score 0-1 point. Having at least one measurable lesion confirmed by the RECIST 1.1. Locoregionally advanced nasopharyngeal carcinoma patients, who have never received systematic treatment for recurrent or metastatic lesion, was found with recurrence or metastasis in at least 6 months after completing chemotherapy and radiotherapy of the primary lesion. Never receive immune-checkpoint inhibitors (anti-PD-1 monoclonal antibody or anti PD-L1 monoclonal antibody, etc) treatment. In radical treatment phase of locoregional nasopharyngeal carcinoma, patients received no more than 1 type of immune-checkpoint inhibitor (limited to CTLA-4/PD-1/PD-L1 monoclonal antibody, not including bi-specific antibody or penpulimab) can be included: i: If the patient received immune-checkpoint inhibitors (with or without other drugs) during induction therapy, the optimal treatment effect should be PR or better than PR. ii: If the patient received immune-checkpoint inhibitors (with or without other drugs) during radiotherapy, there should be no progression during treatment and within 6 months after treatment. According to the researchers' judgement, the target lesion cannot benefit from radiotherapy. The major organs' function is normal, and meets following criteria 7 days before intervention: Blood routine should meet (No blood transfusion or blood product within the past 14 days, and no correction was used with G-CSF or other hematopoietic stimulating factors.): Hemoglobin (HB) ≥ 90g/L; White blood cell (WBC) ≥ 4*109/L; Blood platelet (PLT): 100_109/L; Biochemistry examination should meet: Total bilirubin (TBIL) ≤ 1.5*upper limit of normal (ULN); Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5*ULN; Serum creatinine (Cr) ≤ 1.5×ULN and creatinine clearance (CCr) ≥ 60ml/min; Coagulation function: INR and APTT ≤ 1.5*ULN; Myocardial injury, heart failure three indexes examination, electrocardiogram results are normal; For patients with abnormalities in these three examinations, the researchers will assess whether to add Doppler ultrasound. Thyroid gland function: TSH ≤ ULN; If not, including those whose FT3 and FT4 levels are normal, and excluding others. Fertile women must already used reliable contraceptive measures or have negative gestational test (serum) result within the 7 days before inclusion. And they are willing to take suitable contraceptive measures during the clinical trial and the 8 weeks after the last administration of intervention or have sterilized. Men must take suitable contraceptive measures during the clinical trial and the 8 weeks after the last administration of intervention or have been surgically sterilized. Patient has signed the informed consent and has good compliance. Exclusion Criteria: Patients who meet any of the following criteria should be excluded: Disease progression within 6 months after the standard therapy of locoregional advanced nasopharyngeal carcinoma; Patients who cannot accept MR examination for metal implant or claustrophobia; Patients who need systemically using glucocorticoid (> 10mg prednisone per day) or other immunosuppressive drugs treatment in 14 days before intervention or during intervention. If the patient doesn't have active autoimmune disease, it is allowed to use invasive or topical corticosteroid and adrenocorticotropic hormone (ACTH) that is equivalent to > 10mg/day prednisone, and ACTH replacement therapy that is equivalent to ≤ 10mg/ day prednisone therapeutic dose. Patient who has recurrent lesion that is suitable for operation or second-course radiotherapy or, based on the judgement of the doctor in charge, can profit from the radiotherapy for the target lesion. Patient has active immune or autoimmune disease history, or known allograft history, or allogeneic hematopoietic stem cell transplantation history, excluding type 1 diabetes, hypothyroidism that need hormone replacement therapy and dermatologic diseases that don't need systemic treatment (e.g. leucoderma, psoriasis and alopecia.). Patients who had active or uncontrolled severe infection (≥ CTCAE level 3 infection) within the 4 weeks before inclusion; Patient who had active tuberculosis history in the past 1 year, with or without treatment. Apart from those with a proven history of regular antituberculosis therapy, patients with > 1-year active pulmonary tuberculosis history should be excluded. Patients with hypertension history, and their blood pressure was not well-controlled (systolic pressure ≥ 150 mmHg or diastolic pressure ≥ 90 mmHg) after 1 kind of drug treatment. Having significant clinical ischemia symptom or specific ischemia tendency, especially to exclude locoregional recurrent cases with high risk of ischemia; Urine routine examination revealed urine protein ≥ ++, and is proven that 24-h urinary protein volume ≥ 1.0g; Patients who had ≥ level I myocardial ischemia, myocardial infarction, arrythmia (including QTc ≥ 480ms) or ≥ level 2 congestive heart failure (New York Heart Association, NYHA) during the 6 months before inclusion. If the patient need Doppler ultrasound examination (the 4th of inclusion criteria 5), the abnormal result is when left ventricular ejection fraction (LVEF) < lower limit of normal (60%); Patient who has been diagnosed with other malignant carcinoma, excluding cured non-melanoma skin cancer, carcinoma in situ of cervix or papillary thyroid carcinoma; Existed meningeal metastasis or central nerve system metastasis; HIV positive, TP positive, liver cirrhosis, decompensated liver disease, active hepatitis (active hepatitis that were not well-controlled after treatment (Hepatitis B: HBsAg positive and HBV DNA ≥ 1*104 copies/ml; Hepatitis C: HCV RNA positive and abnormal hepatic function; the co-infection of hepatitis B and hepatitis C), and need to receive antiviral treatment; Patients who have participated in other anti-tumor drug-related clinical trial in the 4 weeks before inclusion; Patients who have received attenuated live vaccine or AK-105 treatment in the 30 days before inclusion; Patients who had severe hypersensitivity history to other monoclonal antibody; Patients who had great difficulty for oral drugs, e.g. cannot swallow, chronic diarrhea and bowel congestion, etc. Patients with mental drug abuse history and cannot withdrawal or mental disorder; There are conditions that, in the investigator's judgment, seriously endanger patient safety, may confuse the study results, or concomitant diseases or any other situations that affect the patient's completion of the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention arm

    Arm Description

    First, patients will receive the combination treatment of anlotinib, penpulimab and capecitabine every three weeks for 4-6 cycles. 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 from day 1 to day 21. Then a maintenance treatment will be run with "penpulimab and capecitabine"(the dose and the medication method remain the same) for every 3 weeks until PD or intolerance to drug toxicity. Note: After using the penpulimab for 2 years, it is dependent on the researcher's judgement of the benefit evaluation whether to continue using it.

    Outcomes

    Primary Outcome Measures

    Progression-free survival (PFS)
    Progression-free survival is measured according to the RECIST 1.1.

    Secondary Outcome Measures

    Objective remission rate (ORR)
    Objective remission rate is measured according to the RECIST 1.1.
    Progression-free survival (PFS)
    Progression-free survival is measured according to the iRECIST.
    Overall survival (OS)
    Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.
    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).
    Quality of Life (QoL)
    Quality of Life is measured by the FACT-H&N designed by The Center on Outcomes Research and Education.
    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.

    Full Information

    First Posted
    March 28, 2023
    Last Updated
    September 1, 2023
    Sponsor
    Sun Yat-sen University
    Collaborators
    Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05807880
    Brief Title
    Anlotinib, Penpulimab and Capecitabine in Recurrent/Metastatic Nasopharyngeal Carcinoma
    Acronym
    ALTER-HN005
    Official Title
    The First-line Therapy With the Combination of Anlotinib, Penpulimab and Capecitabine in Recurrent/Metastatic Nasopharyngeal Carcinoma: a Single-arm, Open-label, Phase II Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    October 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sun Yat-sen University
    Collaborators
    Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nasopharyngeal Neoplasms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    The combination of anlotinib, penpulimab and capecitabine.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention arm
    Arm Type
    Experimental
    Arm Description
    First, patients will receive the combination treatment of anlotinib, penpulimab and capecitabine every three weeks for 4-6 cycles. 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 from day 1 to day 21. Then a maintenance treatment will be run with "penpulimab and capecitabine"(the dose and the medication method remain the same) for every 3 weeks until PD or intolerance to drug toxicity. Note: After using the penpulimab for 2 years, it is dependent on the researcher's judgement of the benefit evaluation whether to continue using it.
    Intervention Type
    Drug
    Intervention Name(s)
    The combination treatment of anlotinib, penpulimab and capecitabine.
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Progression-free survival (PFS)
    Description
    Progression-free survival is measured according to the RECIST 1.1.
    Time Frame
    3-year
    Secondary Outcome Measure Information:
    Title
    Objective remission rate (ORR)
    Description
    Objective remission rate is measured according to the RECIST 1.1.
    Time Frame
    Median value
    Title
    Progression-free survival (PFS)
    Description
    Progression-free survival is measured according to the iRECIST.
    Time Frame
    3-year
    Title
    Overall survival (OS)
    Description
    Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.
    Time Frame
    3-year
    Title
    Quality of Life (QoL)
    Description
    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).
    Time Frame
    3-year
    Title
    Quality of Life (QoL)
    Description
    Quality of Life is measured by the FACT-H&N designed by The Center on Outcomes Research and Education.
    Time Frame
    3-year
    Title
    Incidence of toxicities
    Description
    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.
    Time Frame
    3-year

    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: Participants will be included only when they meet all inclusion criteria. Between 18 to 65 years old. ECOG PS score 0-1 point. Having at least one measurable lesion confirmed by the RECIST 1.1. Locoregionally advanced nasopharyngeal carcinoma patients, who have never received systematic treatment for recurrent or metastatic lesion, was found with recurrence or metastasis in at least 6 months after completing chemotherapy and radiotherapy of the primary lesion. Never receive immune-checkpoint inhibitors (anti-PD-1 monoclonal antibody or anti PD-L1 monoclonal antibody, etc) treatment. In radical treatment phase of locoregional nasopharyngeal carcinoma, patients received no more than 1 type of immune-checkpoint inhibitor (limited to CTLA-4/PD-1/PD-L1 monoclonal antibody, not including bi-specific antibody or penpulimab) can be included: i: If the patient received immune-checkpoint inhibitors (with or without other drugs) during induction therapy, the optimal treatment effect should be PR or better than PR. ii: If the patient received immune-checkpoint inhibitors (with or without other drugs) during radiotherapy, there should be no progression during treatment and within 6 months after treatment. According to the researchers' judgement, the target lesion cannot benefit from radiotherapy. The major organs' function is normal, and meets following criteria 7 days before intervention: Blood routine should meet (No blood transfusion or blood product within the past 14 days, and no correction was used with G-CSF or other hematopoietic stimulating factors.): Hemoglobin (HB) ≥ 90g/L; White blood cell (WBC) ≥ 4*109/L; Blood platelet (PLT): 100_109/L; Biochemistry examination should meet: Total bilirubin (TBIL) ≤ 1.5*upper limit of normal (ULN); Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5*ULN; Serum creatinine (Cr) ≤ 1.5×ULN and creatinine clearance (CCr) ≥ 60ml/min; Coagulation function: INR and APTT ≤ 1.5*ULN; Myocardial injury, heart failure three indexes examination, electrocardiogram results are normal; For patients with abnormalities in these three examinations, the researchers will assess whether to add Doppler ultrasound. Thyroid gland function: TSH ≤ ULN; If not, including those whose FT3 and FT4 levels are normal, and excluding others. Fertile women must already used reliable contraceptive measures or have negative gestational test (serum) result within the 7 days before inclusion. And they are willing to take suitable contraceptive measures during the clinical trial and the 8 weeks after the last administration of intervention or have sterilized. Men must take suitable contraceptive measures during the clinical trial and the 8 weeks after the last administration of intervention or have been surgically sterilized. Patient has signed the informed consent and has good compliance. Exclusion Criteria: Patients who meet any of the following criteria should be excluded: Disease progression within 6 months after the standard therapy of locoregional advanced nasopharyngeal carcinoma; Patients who cannot accept MR examination for metal implant or claustrophobia; Patients who need systemically using glucocorticoid (> 10mg prednisone per day) or other immunosuppressive drugs treatment in 14 days before intervention or during intervention. If the patient doesn't have active autoimmune disease, it is allowed to use invasive or topical corticosteroid and adrenocorticotropic hormone (ACTH) that is equivalent to > 10mg/day prednisone, and ACTH replacement therapy that is equivalent to ≤ 10mg/ day prednisone therapeutic dose. Patient who has recurrent lesion that is suitable for operation or second-course radiotherapy or, based on the judgement of the doctor in charge, can profit from the radiotherapy for the target lesion. Patient has active immune or autoimmune disease history, or known allograft history, or allogeneic hematopoietic stem cell transplantation history, excluding type 1 diabetes, hypothyroidism that need hormone replacement therapy and dermatologic diseases that don't need systemic treatment (e.g. leucoderma, psoriasis and alopecia.). Patients who had active or uncontrolled severe infection (≥ CTCAE level 3 infection) within the 4 weeks before inclusion; Patient who had active tuberculosis history in the past 1 year, with or without treatment. Apart from those with a proven history of regular antituberculosis therapy, patients with > 1-year active pulmonary tuberculosis history should be excluded. Patients with hypertension history, and their blood pressure was not well-controlled (systolic pressure ≥ 150 mmHg or diastolic pressure ≥ 90 mmHg) after 1 kind of drug treatment. Having significant clinical ischemia symptom or specific ischemia tendency, especially to exclude locoregional recurrent cases with high risk of ischemia; Urine routine examination revealed urine protein ≥ ++, and is proven that 24-h urinary protein volume ≥ 1.0g; Patients who had ≥ level I myocardial ischemia, myocardial infarction, arrythmia (including QTc ≥ 480ms) or ≥ level 2 congestive heart failure (New York Heart Association, NYHA) during the 6 months before inclusion. If the patient need Doppler ultrasound examination (the 4th of inclusion criteria 5), the abnormal result is when left ventricular ejection fraction (LVEF) < lower limit of normal (60%); Patient who has been diagnosed with other malignant carcinoma, excluding cured non-melanoma skin cancer, carcinoma in situ of cervix or papillary thyroid carcinoma; Existed meningeal metastasis or central nerve system metastasis; HIV positive, TP positive, liver cirrhosis, decompensated liver disease, active hepatitis (active hepatitis that were not well-controlled after treatment (Hepatitis B: HBsAg positive and HBV DNA ≥ 1*104 copies/ml; Hepatitis C: HCV RNA positive and abnormal hepatic function; the co-infection of hepatitis B and hepatitis C), and need to receive antiviral treatment; Patients who have participated in other anti-tumor drug-related clinical trial in the 4 weeks before inclusion; Patients who have received attenuated live vaccine or AK-105 treatment in the 30 days before inclusion; Patients who had severe hypersensitivity history to other monoclonal antibody; Patients who had great difficulty for oral drugs, e.g. cannot swallow, chronic diarrhea and bowel congestion, etc. Patients with mental drug abuse history and cannot withdrawal or mental disorder; There are conditions that, in the investigator's judgment, seriously endanger patient safety, may confuse the study results, or concomitant diseases or any other situations that affect the patient's completion of the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jun Ma, M.D.
    Phone
    +862087343469
    Email
    majun@sysucc.org.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cheng Xu, M.D.
    Phone
    +862087343500
    Email
    xucheng@sysucc.org.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jun Ma, M.D.
    Organizational Affiliation
    Sun Yat-sen University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Anlotinib, Penpulimab and Capecitabine in Recurrent/Metastatic Nasopharyngeal Carcinoma

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