Combining Anrotinib and Tirelizumab for treating advanced nasopharyngeal carcinoma

Anrotinib Combined With Tirelizumab in First-line Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma

This study is testing a new combination of two drugs, Anrotinib and Tirelizumab, to see if they can help people with advanced nasopharyngeal cancer who can't or don't want to have chemotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhongshan People's Hospital, Guangdong, China (Academic / other)
• Drugs / interventions: Tirelizumab, prednisone, Anrotinib
• Locations: 1 site (Zhongshan, Guangdong)
• Trial ID: NCT05981157 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial evaluates the safety and efficacy of Anrotinib and Tirelizumab as a first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma. The study focuses on patients who have histologically confirmed nonkeratinizing NPC and measurable lesions. Participants must have an ECOG performance status of 0 to 2 and a life expectancy of more than 12 weeks, while being unable or unwilling to undergo chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are patients with advanced recurrent or metastatic nasopharyngeal carcinoma who have measurable lesions and meet specific health criteria.

Not a fit: Patients with uncontrolled significant medical conditions or those who can tolerate chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced nasopharyngeal carcinoma who are not candidates for chemotherapy.

How similar studies have performed: While this approach combines targeted therapy and immunotherapy, similar studies have shown promise in treating other cancers, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC (AJCC, 8th; the metastatic tissue biopsy is preferred, not necessary; locoregional recurrent lesion unfit for local treatment).
2. Subjects enrolled must have measurable lesion(s) according to response evaluation criteria in solid (RECIST) v1.1.
3. ECOG performance status of 0～2
4. Life expectancy more than 12 weeks.
5. unable or unwilling to undergo chemothraphy
6. Able to understand and sign an informed consent form (ICF).

Exclusion Criteria:

1. Uncontrolled clinically significant medical condition, including but not limited to the following: Hypertension that cannot be reduced to the normal range after antihypertensive drug congestive heart failure (New York Health Authority Class \> 2), unstable angina, myocardial infarction within the past 12 months, clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention;
2. Known history of hypersensitivity to any components of the Tirelizumab formulation or other monoclonal antibodies ;
3. Diagnosed with other malignant tumors.
4. Subjects with any active autoimmune disease or history of autoimmune disease, or history of syndrome that requires systemic steroids or immunosuppressive medications, including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Subjects with the following conditions will not be excluded from this study: asthma that requires intermittent use of bronchodilators, hypothyroidism stable on hormone replacement, vitiligo, Graves' disease, or Hashimoto's disease. Additional exceptions may be made with medical monitor approval;
5. Subjects with medical condition affecting oral drug absorption, such as dysphagia, chronic diarrhea and intestinal obstruction.
6. Active bleeding, ulcer, intestinal perforation, major surgery in the previous month; Patients with tumors close to the internal carotid artery or other large vessels, thus at risk of massive bleeding.
7. The laboratory test values within 7 days before enrollment do not meet the relevant standards.
8. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses 10 mg/day prednisone or equivalent are prohibited within 4 weeks before study drug administration. Note: corticosteroids used for the purpose of IV contrast allergy prophylaxis are allowed;
9. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease; active tuberculosis (TB), anti-TB treatment is ongoing or within 1 year prior to screening; Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation based on institutional guidelines and tests. Testing may include the following: HBV DNA, HCV RNA, hepatitis B surface antigen, or anti-Hepatitis B core antibody.
10. Subjects with comorbidities with long-term immunosuppressive drug therapy, or with systemic or local use of immunosuppressive doses of corticosteroids.
11. Subjects who underwent anti-PD-1 /PD-L antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell synergistic stimulation or checkpoint pathway) and anti-angiogenic drugs.
12. Received any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment.
13. Any other medical (eg, pulmonary, metabolic, congenital, endocrinal, or CNS disease), psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results;

Where this trial is running

Zhongshan, Guangdong

• Zhongshan City People's Hospital — Zhongshan, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Guiqiong Xu, MD

Conditions Nasopharyngeal Carcinoma; nasopharyngeal carcinoma; Immunotherapy; Molecular Targeted Therapy