Intensified Treatments for Patients With Locally Advanced Nasopharyngeal Carcinoma With Detectable EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy

NCT05772208 | Recruiting Phase 3

• 1 other identifier: 2110244-20
• Study Type: interventional
• Target: 459
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this multicenter randomized non-inferior study is to compare the additon of camrelizumab or nimotuzumab to neoadjuvant chemotherapy followed by concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose EBV DNA remained detectable after one cycle neoadjuvant chemotherapy using GP regimen. The main question it aims to answer is: whether the addition of carrilizumab or nituzumab improve the treatment outcomes in the relatively poor prognostic patients identified by the response of EBV DNA. Participants will be randomized to the combination of carrilizumab and standard treatment , the combination of nituzumab and standard treatment or the standard treatment alone if their EBV DNA didn't decrease to undetectable level post first cycle of neoadjuvant chemotherapy.

Conditions

Nasopharyngeal Carcinoma

Keywords

EBV DNA; camrelizumab; nimotuzumab

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Defined from date of randomization to date of first documentation of progression or death due to any cause

  3 years

Secondary Outcomes (2)

• Overall survival

  3 years

• Toxicities

  3 years

Study Arms (3)

the combination of camrelizumab and standard treatment

EXPERIMENTAL

camrelizumab 200mg q3w 2 cycle combinted with the second and third cycle neoajuvant chemotherapy and camrelizumab 200mg q3w 8 cycle starting one month after concurrent chemo-radiotherapy.

Drug: Camrelizumab; Drug: neoadjuvant chemotherapy and CCRT

the combination of nimotuzumab and standard treatment

EXPERIMENTAL

nimotuzumab 200mg qw combined with the second and third cycle neoajuvant chemotherapy and nimotuzumab 200mg qw used during chemo-radiotherapy.

Drug: Nimotuzumab; Drug: neoadjuvant chemotherapy and CCRT

standard treatment

ACTIVE COMPARATOR

the second and third neoajuvant chemotherapy with GP regimen (gemcitabine 1g/m2 d1，8 plus cisplatin 75mg/m2 ) concurrent chemotherapy: single cisplatin (80mg/m2) for two cycle definitive radiotherapy for primay lesion and lymph node region.

Drug: neoadjuvant chemotherapy and CCRT

Interventions

Camrelizumab DRUG

camrelizumab 200mg q3w

the combination of camrelizumab and standard treatment

Nimotuzumab DRUG

nimotuzumab 200mg qw

the combination of nimotuzumab and standard treatment

neoadjuvant chemotherapy and CCRT DRUG

the second and third neoajuvant chemotherapy with GP regimen (gemcitabine 1g/m2 d1，8 plus cisplatin 75mg/m2 ) concurrent chemotherapy: single cisplatin (80mg/m2) for two cycle definitive radiotherapy for primay lesion and lymph node region.

standard treatment; the combination of camrelizumab and standard treatment; the combination of nimotuzumab and standard 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:

• Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, EGFR+.
• Age 18-70 years.
• Clinical stage III-IVa (based on the 8th American Joint Committee on Cancer\[AJCC\] edition).
• Patients with detectable pre-treatment plasma EBV DNA which remained detectable after one cycle neoadjuvant.
• ECOG (Eastern Cooperative Oncology Group) score: 0-1
• Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L.
• Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)\< 1.5 times the upper limit of normal value (ULN), total bilirubin \<1.0×ULN.
• Renal function: serum creatinine \<1×ULN.
• Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.

You may not qualify if:

• Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
• Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
• Receiving radiotherapy or chemotherapy or targeted therapy previously
• Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
• Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
• Severe, uncontrolled medical conditions and infections.
• At the same time using other test drugs or in other clinical trials.
• Refusal or inability to sign informed consent to participate in the trial.
• Emotional disturbance or mental

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan Universtiy Shanghai Cancer Centre

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

camrelizumab; nimotuzumab; Neoadjuvant Therapy

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)

Combined Modality Therapy; Therapeutics

Central Study Contacts

Chengrun Du

CONTACT

+86-15001733593; duchengrun@qq.com

Study Design

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

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: January 1, 2022
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

CN (1)