Efficacy and Safety of TPC+Apatinib+Camrelizumab vs GP+ Camrelizumab for High-Risk Nasopharyngeal Carcinoma: A Phase 3 Trial

NCT06438627 | Recruiting Phase 3

• 1 other identifier: SYSKY-2024-267-02
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to evaluate the efficacy and safety of the TPC regimen (nab-paclitaxel, cisplatin, and capecitabine) combined with apatinib and camrelizumab versus the GP regimen (gemcitabine and cisplatin) combined with camrelizumab for the treatment of high-risk regionally advanced nasopharyngeal carcinoma with a high risk of distant metastasis. The evaluation will be conducted through a prospective, controlled, open-label, multicenter phase 3 clinical trial in areas with high incidence of nasopharyngeal carcinoma.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 3-years FFS

  3-years failure-free survival rate

  up to 3 years

Secondary Outcomes (4)

• DMFS

  up to 3 years

• OS

  up to 3 years

• LRFS

  up to 3 years

• ORR

  up to 3 years

Study Arms (2)

TPC+Apatinib+Camrelizumab

EXPERIMENTAL

Radiation: IMRT Drug: Nab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab (Induction chemotherapy)

Drug: TPC combined with Apatinib and Camrelizumab

GP+ Camrelizumab

ACTIVE COMPARATOR

Radiation: IMRT Drug: Gemcitabine, Cisplatin Combined With Camrelizumab (Induction chemotherapy)

Drug: GP Combined With Camrelizumab

Interventions

TPC combined with Apatinib and Camrelizumab DRUG

Nab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab

TPC+Apatinib+Camrelizumab

GP Combined With Camrelizumab DRUG

Gemcitabine, Cisplatin regimen Combined With Camrelizumab

GP+ Camrelizumab

Eligibility Criteria

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

You may qualify if:

• Pathologically confirmed WHO type II or III;
• Staging TanyN3M0 (UICC/AJCC 8th edition);
• Treatment-naive patients with no history of other malignancies;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Age 18-65 years;
• Neutrophils ≥1.5×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥90 g/L, transaminases \<2.5 times the upper limit of normal, total bilirubin \<1.5 times the upper limit of normal, creatinine \<1.5 times the upper limit of normal; activated partial thromboplastin time and international normalized ratio \<1.5 times the upper limit of normal;
• Signed informed consent form.

You may not qualify if:

• Known or suspected allergy to the study drugs, or pregnant/perinatal women;
• Inability to comply with regular follow-up due to psychological, social, familial, or geographical reasons;
• Severe dysfunction of critical organs such as the heart, lungs, liver, or kidneys (e.g., decompensated heart, lung, renal, or liver failure) that precludes tolerance to chemoradiotherapy;
• Severe uncontrolled infection or internal medical disease;
• Factors affecting drug administration, distribution, metabolism, or excretion such as psychiatric disorders, central nervous system abnormalities, chronic diarrhea, ascites, or pleural effusion;
• Poorly controlled hypertension despite antihypertensive treatment (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg);
• Long-term use of immunosuppressants post-organ transplantation;
• Known history of substance abuse or drug addiction;
• History of other malignancies prior to enrollment;
• Presence of other severe physical or mental illnesses or abnormal laboratory findings that may increase the risk of study participation, interfere with study results, or deemed unsuitable for participation by the investigator.

Sponsors & Collaborators

• XIANG YANQUN: lead

Study Sites (2)

SunYat-senU

Guangzhou, Guangdong, 510060, China

RECRUITING

Sun Yat sen Memorial Hospital

Guangzhou, China

RECRUITING

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 Officials

• Yanqun Xiang

  SunYat-sen U

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqun Xiang

CONTACT

18666096623; xiangyq@syscc.org.cn

Guoying Liu

CONTACT

18127919832; liugy0109@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 3, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2029
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)