Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 ®)。

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Sichuan Cancer Hospital
RECRUITING
Chengdu
Contact Information
Primary
MEI FENG, doctor
freda_fm@126.com
13076000700
Time Frame
Start Date: 2022-04-20
Estimated Completion Date: 2027-10-30
Participants
Target number of participants: 170
Treatments
Experimental: Experimental group
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.
Placebo_comparator: control group
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
Related Therapeutic Areas
Sponsors
Leads: Sichuan Cancer Hospital and Research Institute

This content was sourced from clinicaltrials.gov