Clincosm LogoSign in Get a demo

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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05807880
Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)
110
Enrollment
1
Arm
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: The combination treatment of anlotinib, penpulimab and capecitabine.
 Phase 2

Detailed Description

The trial plans to enroll nasopharyngeal carcinoma patients with first-diagnosed metastasis or recurrence/metastasis after local treatment and never receive systemic treatment for recurrent/metastatic lesion. Patients will be treated with anlotinib, penpulimab and capecitabine every three weeks until PD or intolerance to toxicity.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The combination of anlotinib, penpulimab and capecitabine.The combination of anlotinib, penpulimab and capecitabine.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention arm

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival (PFS） [3-year]

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

Secondary Outcome Measures

  1. Objective remission rate (ORR) [Median value]

    Objective remission rate is measured according to the RECIST 1.1.

  2. Progression-free survival (PFS) [3-year]

    Progression-free survival is measured according to the iRECIST.

  3. Overall survival (OS) [3-year]

    Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.

  4. Quality of Life (QoL) [3-year]

    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).

  5. Quality of Life (QoL) [3-year]

    Quality of Life is measured by the FACT-H&N designed by The Center on Outcomes Research and Education.

  6. Incidence of toxicities [3-year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  • Histologically or cytologically proven nasopharyngeal carcinoma and was defined as stage IVb by AJCC (8th edition) or recurrent nasopharyngeal carcinoma patients that are not suitable for topical treatment (For neoadjuvant/adjuvant treatment and radical concurrent chemoradiotherapy, if the disease progress during treatment or within 6 months after treatment, it is regarded as the failure of original first-line treatment, while others are regarded as success of the original first-line treatment. Patients whose treatment plan was changed for drug intolerance are not regarded as treatment failure.).

  • 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.

  • The major organs' function is normal, and meets following criteria 7 days before intervention:

  1. Blood routine should meet (No blood tranfusion or blood product within the past 14 days, and no correction was used with G-CSF or other hematopoietic stimulating factors.):

  2. Hemoglobin (HB) ≥ 90g/L;

  3. White blood cell (WBC) ≥ 4*109/L;

  4. Blood platelet (PLT): 100_109/L;

  5. Biochemistry examination should meet:

  6. Total bilirubin (TBIL) ≤ 1.5*upper limit of normal (ULN);

  7. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5*ULN;

  8. Serum creatinine (Cr) ≤ 1.5×ULN and creatinine clearance (CCr) ≥ 60ml/min;

  9. Coagulation function: INR and APTT ≤ 1.5*ULN;

  10. 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.

  11. 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 use 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.

  • Patients who planed to receive radiotherapy during this clinical trial.

  • 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 perfusive 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sun Yat-sen University
  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

  • Principal Investigator: Jun Ma, M.D., Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jun Ma, MD, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05807880
Other Study ID Numbers:
  • ALTER-HN005
First Posted:
Apr 11, 2023
Last Update Posted:
Apr 11, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Nasopharyngeal Carcinoma
Nasopharyngeal Neoplasms
Capecitabine

Study Results

No Results Posted as of Apr 11, 2023