Nituzumab (Taixinsheng ®） A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study on the Efficacy and Safety of Combined Induction Chemotherapy for Locally Advanced Nasopharyngeal Carcinomatreatment of Locally Advanced Nasopharyngeal Carcinoma

NCT05508347 | Recruiting Phase 2

• 1 other identifier: Ahead-NC-202203
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Nasopharyngeal carcinoma (NPC) is a head and neck tumor. Studies have shown that more than 70% of patients are diagnosed with locally advanced nasopharyngeal carcinoma at the time of initial diagnosis. The 3-year survival rate of locally advanced nasopharyngeal carcinoma after chemotherapy is over 90%, but 30% of patients still have recurrence and distant metastasis. Therefore, while improving the level of radiation therapy technology, we should study multidisciplinary comprehensive treatment methods and put forward the biological concept of "cure". Induction chemotherapy can effectively create better radiotherapy conditions for locally advanced nasopharyngeal carcinoma, especially for patients with large lesions, improve the treatment response rate, and may reduce the local recurrence and distant metastasis rate. After the end of neoadjuvant chemotherapy, compared with patients who only reached SD, patients who reached CR had a significant survival benefit; Other patients had a reduced rate of distant metastasis, which aroused our interest, although there was no obvious survival benefit. The national multicenter phase II clinical study showed that nitumab combined with radiotherapy significantly improved the 3-year survival rate of patients with locally advanced nasopharyngeal carcinoma compared with radiotherapy alone. According to the previous related research results, nitumab combined with induction chemotherapy or concurrent chemoradiotherapy has a certain effect on nasopharyngeal carcinoma without obvious adverse reactions. However, prospective studies on the short-term efficacy and safety of local advanced nasopharyngeal carcinoma combined with induction chemotherapy and concurrent chemoradiotherapy are still lacking (Taisheng ®）。

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Complete response rate after induction treatment period

  Complete remission (CR) rate within 5 days before the start of concurrent chemoradiotherapy after 3 cycles of induction chemotherapy

  2 months after the start of treatment

Secondary Outcomes (8)

• Objective response (ORR) rate

  3 months after the start of treatment

• The tumor regression rate (TRR)

  2 months after the start of treatment

• Objective remission (ORR)

  2 months after the start of treatment

• Complete remission (CR) rate

  3 months after the start of treatme

• disease-free survival (DFS) rate

  3, 5-year

Study Arms (2)

Experimental group

EXPERIMENTAL

3 cycles of docetaxel combined with cisplatin induction chemotherapy combined with 9 times of 200mg nituzumab targeted therapy, and sequential 2-3 cycles of concurrent chemoradiotherapy based on cisplatin chemotherapy combined with 7 times of nituzumab targeted therapy.

Drug: Nituzumab/placebo

control group

PLACEBO COMPARATOR

3 cycles of docetaxel combined with cisplatin induction chemotherapy combined with 9 times of placebo treatment, and sequential 2-3 cycles of concurrent chemoradiotherapy based on cisplatin chemotherapy combined with 7 times of nituzumab targeted therapy

Drug: Nituzumab/placebo

Interventions

Nituzumab/placebo DRUG

Test group: 3 cycles of induction chemotherapy combined with 9 times of nituzumab targeted therapy followed by 2-3 cycles of synchronous radiotherapy and chemotherapy combined with 7 times of nituzumab targeted therapy, a total of 16 times of nituzumab targeted therapy, equivalent to the whole course targeted therapy. Control group: 3 cycles of induction chemotherapy combined with 9 times of placebo treatment followed by 2-3 cycles of concurrent chemoradiotherapy combined with 7 times of nituzumab targeted therapy, a total of 7 times of nituzumab targeted therapy, only targeted therapy during concurrent chemoradiotherapy

Also known as: Nituzumab injection (taixinsheng)

Experimental group; control group

Eligibility Criteria

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

You may qualify if:

• Voluntarily participate and sign the informed consent in writing.
• Age: 18-70 years old, gender is not limited.
• Nasopharynx squamous cell carcinoma diagnosed by histopathology.
• Nasopharyngeal carcinoma 2018 AJCC (Eighth Edition) staging: t2-4n2m0 (metastatic lymph nodes have one of the following risk factors: the shortest length of the largest lymph node is ≥ 3cm or the lymph node is liquefied and necrotic or the lymph node envelope is invaded) or t1-4n3m0.
• Immunohistochemistry: EGFR (+).
• The primary tumor can be measured.
• Kaplan score \> 70.
• Survival expectation ≥ 6 months.
• Women in childbearing period should ensure to take effective contraception during the study period.
• Hemoglobin (Hgb) ≥ 90 g / L, white blood cell (WBC) ≥ 4 × 109 / L, platelet (PLT) ≥ 90 × 109 /L.
• Liver function: ALT and / or ast \< 1.5 times the upper limit of normal value (ULN), and TBIL \< 1.5 times the upper limit of normal value (ULN).
• Renal function: serum creatinine \< 1.5 times the upper limit of normal value (ULN); Creatinine clearance rate shall not be lower than 60ml / min.

You may not qualify if:

• There is evidence of distant metastasis.
• The primary tumor or lymph node has been treated surgically (except biopsy).
• Patients with primary focus or lymph nodes who have received radiotherapy.
• Those who have received epidermal growth factor targeted therapy.
• The primary lesion has received chemotherapy or immunotherapy.
• Have had other malignant tumors (except non melanoma skin cancer or cervical carcinoma in situ).
• Subjects who have received other drug tests in the past 1 month.
• \> grade I peripheral neuropathy.
• Pregnant or lactating women and women of childbearing age who refuse contraception during the treatment observation period.
• Those with severe allergic history or special constitution.
• A history of severe lung or heart disease.
• Known to be infected with HIV virus or active viral hepatitis.
• Received live vaccine within 30 days of the planned start of study drug treatment.
• Those who refuse or cannot sign the informed consent form.
• Drug or alcohol addicts.

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

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

• MEI FENG, doctor

  四川省肿瘤研究所

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MEI FENG, doctor

CONTACT

13076000700; freda_fm@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: August 19, 2022
• Study Start: April 20, 2022
• Primary Completion: October 30, 2025
• Study Completion (Estimated): October 30, 2027
• Last Updated: April 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)