Anti-PD1 Monoclonal Antibody Combined With Nimotuzumab and Capecitabine in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma

NCT06259721 | Recruiting Phase 2

• 1 other identifier: INC-RMNPC
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the efficacy and safety of a combination regimen of Anti-PD1 monoclonal antibody, nimotuzumab, and capecitabin in treating recurrent or metastatic nasopharyngeal carcinoma patients who have failed first-line platinum-based chemotherapy.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma; anti-PD1 antibody; Nimotuzumab; Capecitabine

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  An objective response is defined as either a confirmed CR or a PR, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST1.1) from the National Cancer Institute (NCI) An objective response is defined as either a confirmed CR or a PR, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST1.1) from the National Cancer Institute (NCI) An objective response is defined as either a confirmed CR or a PR, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST1.1) from the National Cancer Institute (NCI)

  6 months

Secondary Outcomes (5)

• Disease control rate

  6 months

• Duration of response

  1 year

• Overall survival rate

  2 years

• Progression-free survival rate

  2 years

• Incidence rate of adverse events (AEs)

  2 years

Study Arms (1)

Combination Treatment

EXPERIMENTAL

Drug: Anti-PD1 antibody, nimotuzumab and capecitabine

Interventions

Anti-PD1 antibody, nimotuzumab and capecitabine DRUG

Combination phase Anti-PD1 monoclonal antibody: Choose one of the anti-PD-1 monoclonal antibody drugs reimbursed by medical insurance, toripalimab (240mg), camrelizumab (200mg), tislelizumab (200mg) or others; Intravenous infusion, every 3 weeks . Nimotuzumab:: In the first 6 cycles, 200 mg, intravenous infusion, every 1 week, and 400 mg is administered for the first time. Capecitabine: 1000 mg/m2, orally twice daily on days 1-14, every 3 weeks Maintenance phase: Anti-PD1 monoclonal antibody: anti-PD-1 monoclonal antibody drugs, Intravenous infusion, every 3 weeks. Nimotuzumab treatment: 400 mg, intravenous infusion, every 3 weeks. Capecitabine: 1000 mg/m2, orally twice daily on days 1-14, every 3 weeks； The duration of treatment is 1 year or until intolerable toxic reactions occur, or disease progresses, or the patient withdraws consent, or the investigator determines that the patient needs to withdraw from treatment.

Combination Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed with recurrent or metastatic nasopharyngeal carcinoma which is not amenable to curative treatment with surgery and/or radiation therapy. If the patient refuses biopsy of metastatic lesions, those diagnosed with metastasis based on imaging evidence and clinical evidence can be enrolled.
• Have failed for first-line platinum-based chemotherapy. Previously received first-line platinum-based chemotherapy for recurrent or metastatic disease and had disease progression during or after treatment; or recurrence and metastases within 6 months after treatment of platinum-based chemoradiation.
• Age ≥ 18 years and ≤ 75 years, both genders.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• The life expectancy of at least 3 months.
• Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria.
• Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment) as determined by:
• Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ 75×109/L; Hemoglobin ≥ 9 g/dL; serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN), (for subjects with liver metastases, TBIL ≤3×ULN; ALT and AST≤5×ULN); Creatinine ≤1.5×ULN or creatinine clearance rate≥50 ml/min (Cockcroft-Gault formula); serum albumin ≥28 g/L; Thyroid-stimulating hormone (TSH) levels ≤1×ULN (however, patients with free Triiodothyronine \[FT3\] or free Thyroxine \[FT4\] levels ≤1× ULN may be enrolled); INR, APTT≤1.5 x ULN.
• All women with fertility potential must undergo a urine or serum pregnancy test during screening and the results are negative.
• Written informed consent.

You may not qualify if:

• \. Those with a history of severe immediate allergy to any drugs used in this study; 2. Patients who have previously received anti-EGFR monoclonal antibodies (nitolizumab, cetuximab) and anti-PD-1 monoclonal antibodies.
• \. Combined with other malignant tumors; 4. Any of the following conditions exist within 6 months before screening: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident, transient cerebral ischemia Paroxysmal or symptomatic pulmonary embolism. Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria, or left ventricular ejection fraction \<50% must be treated with an optimized and stable medical regimen as determined by the treating physician, who may consult a cardiologist if appropriate; 5. Patients who have received any of the following treatments:
• (1) Have received any investigational drugs within 4 weeks before using the investigational drugs for the first time; (2) Use of large amounts of glucocorticoids or other immunosuppressants (including but not limited to prednisone, dexamethasone, azathioprine, methotrexate, thalidomide and anti-tumor necrosis factor within 4 weeks before treatment (drugs against TNF), or subjects who require hormonal therapy during clinical trials. Other special circumstances need to be communicated with the sponsor. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocortical hormone replacement at doses \>10 mg/day prednisone therapeutic dose are allowed; (4) Those who have received anti-tumor vaccines or have received live vaccines within 4 weeks before the first administration of the study drug; (5) Have undergone major surgery or serious trauma within 4 weeks before using the study drug for the first time; (6) Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; 6. Patients with active autoimmune diseases or a history of autoimmune diseases that may relapse
• Note: Patients with the following diseases are not excluded and can enter further screening:
• Controlled type 1 diabetes
• Hypothyroidism (if it can be controlled with hormone replacement therapy alone)
• Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia)
• Any other disease that is not expected to recur in the absence of external triggers 7. Active infections, including tuberculosis, hepatitis B, hepatitis C and human immunodeficiency virus. Patients with positive HBV surface antigen (HBsAg) but HBV DNA \<1000 copies/mL are eligible to participate in this study; patients with positive HCV antibody test results can only participate if the HCV RNA polymerase chain reaction test result is negative. Selected for this study; 8. History of idiopathic pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia (bronchiolitis obliterans), idiopathic pneumonia or evidence of active pneumonia on chest CT scan during screening; 9. No capacity for civil conduct or limited capacity for civil conduct; 10. Drug abuse or alcohol addiction, the patient has physical or mental illness, and the researcher believes that the patient cannot fully or fully understand the possible complications of this study; 11. Other serious acute or chronic medical conditions that may increase the risks related to the treatment of the research protocol, or may interfere with the interpretation of the research results and (according to the investigator's judgment) may make the patient unfit to participate in this study (including immune colitis, inflammatory colitis, Enteropathy, non-infectious pneumonia, pulmonary fibrosis) or mental illness (including dementia and epilepsy, suicidal ideation or behavior recently, within the past year, or active) or abnormal laboratory tests; 12. Previously diagnosed with immunodeficiency or known diseases related to human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); 13. Pregnant or lactating female patients, male or female patients with childbearing potential but unwilling or unable to use contraception during the entire study period and for at least 1 year after the end of the treatment plan; 14. Those with recurrent nasopharyngeal carcinoma are suitable for surgical treatment.

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead

Study Sites (1)

Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

nimotuzumab; Capecitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jingao Li, MD

  NHC Key Laboratory of Personalized Diagnosis and Treatment of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingao Li, MD

CONTACT

86079188300252; lijingao@hotmail.com

Xiaochang Gong, MD

CONTACT

86079188300252; gxcanddw@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 14, 2024
• Study Start: February 10, 2024
• Primary Completion: February 9, 2026
• Study Completion (Estimated): August 9, 2026
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

CN (1)