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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • GP Regimen, Nimotuzumab, Sintilimab

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

This trial has no locations