GP Combined With Nimotuzumab and Sintilimab as Induction Therapy for Nasopharyngeal Carcinoma

NCT06490341 | Not Yet Recruiting Phase 2

• 1 other identifier: NPCTIR001
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if the regimen of gemcitabine, cisplatin combined with nimotuzumab and sintilimab works to treat locally advanced nasopharyngeal carcinoma before chemoradiotherapy. It will also learn about the safety of the regimen. The main questions it aims to answer are:

• Does the regimen increase the number of participants who has a significant tumor shrinkage?
• What medical problems do participants have when taking the regimen? Researchers will evaluate the safety and efficacy of the regimen. Participants will:
• Take the regimen every 21 days, for twice.
• Visit the clinic weekly for drug administration, checkups and tests.
• Keep a diary of their symptoms.

Conditions

Locally Advanced Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• ORR

  objective response rate

  3 months

Secondary Outcomes (6)

• mPFS

  1 year

• mOS

  2 years

• PFS rate

  3 years

• OS rate

  3 years

• Adverse events

  1 year

Study Arms (1)

GP Combined with Nimotuzumab and Sintilimab

EXPERIMENTAL

GP regimen(gemcitabine plus cisplatin) in combination with nimotuzumab and sintilimab

Drug: GP Regimen, Nimotuzumab, Sintilimab

Interventions

GP Regimen, Nimotuzumab, Sintilimab DRUG

gemcitabine,ciplatin, nimotuzumab, sintilimab

Also known as: no other invention names

GP Combined with Nimotuzumab and Sintilimab

Eligibility Criteria

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

You may qualify if:

• Age between 18 and 75 years, inclusive, without gender restriction.
• ECOG Performance Status (PS) score of 0 or 1.
• Histologically confirmed diagnosis of locally advanced nasopharyngeal carcinoma, staged as III-IVa according to the 2018 American Joint Committee on Cancer (AJCC) staging system, with T3-4N2M0 or T1-4N3M0 classification. Tumor types include WHO type II and III.
• 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.
• 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).
• Signed written informed consent form.

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

MeSH Terms

Interventions

nimotuzumab; sintilimab

Study Officials

• He Xiaohui

  Cancer Hospital, CAMS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Sheng

CONTACT

86-10-87788507; medart@126.com

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: June 29, 2024
• First Posted: July 8, 2024
• Study Start: July 20, 2024
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): July 20, 2027
• Last Updated: July 8, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share