Nimotuzumab Combined With TGP as First-line Therapy in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

NCT06509009 | Recruiting Phase 2

• 1 other identifier: TINPC-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn the efficacy and safety of nimotuzumab combined with toripalimab and gemcitabine/cisplatin regimen treatment recurrent/distant-metastasis nasopharyngeal carcinoma.

Conditions

Nasopharyngeal Carcinoma by AJCC V8 Stage

Keywords

nasopharyngeal carcinoma

Outcome Measures

Primary Outcomes (1)

• ORR[RECIST1.1]

  objective response rate assessed by RECIST 1.1

  3 months

Secondary Outcomes (6)

• mPFS

  1 year

• OS

  2 years

• 2-year PFS rate

  2 years

• DCR

  3 months

• DOR

  2 years

Study Arms (1)

Nimotuzumab combine with TGP

EXPERIMENTAL

Base on TGP(Toripalimab, Gemcitabine, and Cisplatin) regimen, the patients will receive Nimotuzamab treatment.

Drug: Nimotuzumab

Interventions

Nimotuzumab DRUG

nimotuzumab, toripalimab, gemcitabine, cisplatin

Also known as: no other invention names

Nimotuzumab combine with TGP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent form.
• Age between 18 and 75 years, inclusive, without gender restriction.
• Histologically confirmed diagnosis of recurrent/distant metastasis nasopharyngeal carcinoma, first line patients and unsuitable for local operation treatment.
• EGFR expression positive.
• Presence of at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and patients who have not undergone definitive treatment.
• ECOG Performance Status (PS) score of 0 or 2.
• Expected survival duration of at least 3 months.
• White blood cell count ≥ 3 × 10\^9/L; absolute neutrophil count ≥ 1.5 × 10\^9/L; platelet count ≥ 100 × 10\^9/L; hemoglobin level ≥ 90 g/L.
• Serum creatinine level ≤ 1.2 mmol/L or creatinine clearance ≥ 60 ml/min.
• Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (in case of liver metastasis, ≤ 3.0 × ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (in case of liver metastasis, ≤ 5.0 × ULN).
• Female patients must have a negative urine pregnancy test prior to study enrollment (this criterion does not apply to patients with bilateral ovarian resection and/or hysterectomy or postmenopausal patients).

You may not qualify if:

• Subjects who have received radiotherapy, chemotherapy, immunosuppressive agents, monoclonal antibodies, oral epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), or anti-angiogenic drugs within the past six months.
• Subjects who have participated in another interventional clinical trial, undergone major surgical procedures, or scheduled for surgery within 30 days prior to screening.
• Patients with severe underlying diseases that preclude tolerance to the treatment.
• History of other malignancies, except for cured cervical carcinoma in situ, skin basal cell carcinoma, or malignancies cured for more than 5 years without recurrence.
• Presence of uncontrolled comorbidities such as heart failure, diabetes mellitus, hypertension, thyroid disorders, psychiatric illnesses, etc.
• Subjects with contraindications to immunotherapy, including those with immune dysfunction diseases (such as rheumatoid arthritis, psoriasis, systemic lupus erythematosus, HIV infection, hepatitis B, hepatitis C, chronic use of steroids for autoimmune diseases), recipients of allogeneic transplants, patients with interstitial lung disease, or those with meningeal metastasis or progressive brain metastasis.
• Allergy to any of the drugs or their components used in the study protocol. Grade 2 or higher peripheral neuropathy or hearing loss according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
• Pregnant women (confirmed by blood or urine human chorionic gonadotropin \[HCG\] test) or lactating mothers, or subjects of reproductive age who are unwilling or unable to adopt effective contraceptive measures until at least 6 months after the last treatment in the study.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medcial Science and Peking Union Medical College

Beijing, Beijing Municipality, 1000000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

nimotuzumab

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

• He Xiaohui

  Department of Medical Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Sheng

CONTACT

86-10-87788507; medart@126.com

He Xiaohui

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: July 19, 2024
• Study Start: August 30, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)