Overview
Anlotinib, Penpulimab and Capecitabine in Recurrent/Metastatic Nasopharyngeal Carcinoma
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2025-06-01
2025-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
First-diagnosed metastasis or recurrence/metastasis NPC Patients will be treated with anlotinib, penpulimab and capecitabine.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Sun Yat-sen UniversityCollaborator:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Treatments:
Capecitabine
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.
- 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.):
1. Hemoglobin (HB) ≥ 90g/L;
2. White blood cell (WBC) ≥ 4*109/L;
3. Blood platelet (PLT): 100_109/L;
2. Biochemistry examination should meet:
1. Total bilirubin (TBIL) ≤ 1.5*upper limit of normal (ULN);
2. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5*ULN;
3. Serum creatinine (Cr) ≤ 1.5×ULN and creatinine clearance (CCr) ≥ 60ml/min;
3. Coagulation function: INR and APTT ≤ 1.5*ULN;
4. 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.
5. 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.