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

NCT ID: NCT05772208

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 459 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2028-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

the combination of camrelizumab and standard treatment

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.

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

camrelizumab 200mg q3w

neoadjuvant chemotherapy and CCRT

Intervention Type: 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.

the combination of nimotuzumab and standard treatment

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

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: DRUG

nimotuzumab 200mg qw

neoadjuvant chemotherapy and CCRT

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

neoadjuvant chemotherapy and CCRT

Intervention Type: 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.

Interventions

Camrelizumab

camrelizumab 200mg q3w

Intervention Type: DRUG

Nimotuzumab

nimotuzumab 200mg qw

Intervention Type: DRUG

neoadjuvant chemotherapy and CCRT

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, EGFR+.

2. Age 18-70 years.

3. Clinical stage III-IVa (based on the 8th American Joint Committee on Cancer[AJCC] edition).

4. Patients with detectable pre-treatment plasma EBV DNA which remained detectable after one cycle neoadjuvant.

5. ECOG (Eastern Cooperative Oncology Group) score: 0-1

6. Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L.

7. Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)< 1.5 times the upper limit of normal value (ULN), total bilirubin <1.0×ULN.

8. Renal function: serum creatinine <1×ULN.

9. 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.

Exclusion Criteria

1. Histologically confirmed keratinizing squamous cell carcinoma (WHO I)

2. Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.

3. Receiving radiotherapy or chemotherapy or targeted therapy previously

4. 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.

5. Patients with significantly lower heart, liver, lung, kidney and bone marrow function.

6. Severe, uncontrolled medical conditions and infections.

7. At the same time using other test drugs or in other clinical trials.

8. Refusal or inability to sign informed consent to participate in the trial.

9. Emotional disturbance or mental

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Chaosu Hu

MD and PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan Universtiy Shanghai Cancer Centre

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chengrun Du

Role: CONTACT

duchengrun@qq.com

+86-15001733593

Facility Contacts

Hongmei Ying, M.D.

Role: primary

yinghongmei2011@sina.com

+8621-64175590 ext. 81400

Other Identifiers

2110244-20

Identifier Type: -

Identifier Source: org_study_id