Apatinib and Camrelizumab in Recurrent or Metastatic Nasopharyngeal Carcinoma With First-line Treatment Failure

NCT04586088 | Unknown Phase 2 DMC

• 1 other identifier: SYSUCC-CMY-2020-2103
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective phase II clinical trial to evaluate the efficacy and safety of apatinib and camrelizumab in recurrent or metastatic nasopharyngeal carcinoma who failed at least the first-line treatment.

Conditions

Nasopharyngeal Carcinoma; Recurrent Nasopharyngeal Carcinoma; Metastatic Nasopharyngeal Carcinoma; Chemotherapy Effect; Immunotherapy; Molecular Targeted Therapy

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Defined as the proportion of patients whose tumors shrink to complete response (CR) or partial response (PR) and remain for a certain period of time according to RECIST 1.1

  1 year

Secondary Outcomes (5)

• The proportion of patients who achieved disease control

  1 year

• The proportion of patients who achieved clinical benefit

  1 year

• median progression-free survival

  1 year

• Duration of response

  1 year

• Adverse events

  1 year

Study Arms (1)

Apatinib plus Camrelizumab arm

EXPERIMENTAL

Subjects receive apatinib plus camrelizumab

Drug: Apatinib plus Camrelizumab

Interventions

Apatinib plus Camrelizumab DRUG

Subjects receive Apatinib, 250mg, QD and Camrelizumab, 200mg, D1, Q3W. Treatment was continued until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or investigator decision.

Apatinib plus Camrelizumab arm

Eligibility Criteria

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

You may qualify if:

• Male or female; 18-70 years of age.
• Subjects diagnosed with pathological confirmed metastatic nasopharyngeal carcinoma, or subjects with recurrent NPC that is unfit for local treatment
• Underwent at least first-line treatment failure
• ECOG performance status of 0 or 1.
• Life expectancy more than 12 weeks.
• Subjects enrolled must have measurable lesion(s) according to response evaluation criteria in solid (RECIST) v1.1.
• Adequate organ function assessed by laboratory parameters during the screening period.
• Female subjects agree not to be pregnant or lactating from beginning of the study screening through at least 3 months after receiving the last dose of study treatment. Both men and women of reproductive potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy.
• Able to understand and sign an informed consent form (ICF).

You may not qualify if:

• 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;
• Known history of hypersensitivity to any components of the Camrelizumab formulation or other monoclonal antibodies ;
• 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;
• 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.
• Abnormal coagulation function (INR\>1.5×ULN, APTT\>1.5×ULN) with bleeding tendency.
• The laboratory test values within 7 days before enrollment do not meet the relevant standards.
• Active central nervous system (CNS) metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive disease);
• Diagnosed with other malignant tumors.
• 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;
• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Ding X, Zhang WJ, You R, Zou X, Wang ZQ, Ouyang YF, Peng L, Liu YP, Duan CY, Yang Q, Lin C, Xie YL, Chen SY, Liu YL, Gu CM, Xie RQ, Huang PY, Hong MH, Hua YJ, Chen MY. Camrelizumab Plus Apatinib in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma: An Open-Label, Single-Arm, Phase II Study. J Clin Oncol. 2023 May 10;41(14):2571-2582. doi: 10.1200/JCO.22.01450. Epub 2023 Feb 3.

  PMID: 36735896 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

apatinib; camrelizumab

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Proffessor

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: May 5, 2020
• Primary Completion: June 2, 2022
• Study Completion: September 5, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

CN (1)