Recruiting PHASE3 Nasopharyngeal Carcinoma

New treatment option for Nasopharyngeal Carcinoma

Official title IC Plus Low-dose Radiation Plus Cadonilimab in LANPC

ClinicalTrials.gov ID: NCT05941741

What this study is testing

What is Chemotherapy?

Chemotherapy is an investigational medicine, being studied as a potential treatment for nasopharyngeal carcinoma.

Also referred to as Induction chemotherapy, Concurrent chemotherapy.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This is a multi-center, open-label, randomized controlled phase III clinical trial in primary diagnosed loco-regionally advanced nasopharyngeal carcinoma (NPC) patients. The purpose of this study is to evaluate the efficacy of induction chemotherapy (IC) combined with low-dose radiation and immune checkpoint inhibitor (ICI) followed by concurrent chemoradiotherapy (CCRT) versus IC+CCRT, and compare the treatment-related adverse events and quality of life in two groups.
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 70

You may be able to join if

  • Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
  • All genders, range from 18-70 years old;
  • ECOG score 0-1;
  • Clinical stage T4N1M0 and T1-4N2-3M0 (AJCC/UICC 8th);
  • Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);

You likely can't join if

  • Distant metastases;
  • Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
  • Have or are suffering from other malignant tumors;
  • Participating in other clinical trials;
  • Pregnancy or lactation;
  • Have uncontrolled cardiovascular disease;
See the full eligibility criteria
Who can join
  • Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
  • All genders, range from 18-70 years old;
  • ECOG score 0-1;
  • Clinical stage T4N1M0 and T1-4N2-3M0 (AJCC/UICC 8th);
  • Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
  • No contraindications to chemotherapy, radiotherapy or immunotherapy;
  • Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, hemoglobin ≥ 9g/L, platelet count ≥ 100×109/L; alanine aminotransferase or aspartate aminotransferase \< 2.5×upper...
  • Sign the consent form.
What rules you out
  • Distant metastases;
  • Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
  • Have or are suffering from other malignant tumors;
  • Participating in other clinical trials;
  • Pregnancy or lactation;
  • Have uncontrolled cardiovascular disease;
  • Severe complication, eg, uncontrolled hypertension;
  • Mental disorder;
  • Drug or alcohol addition;
  • Do not have full capacity for civil acts.

The study team makes the final eligibility decision.

Where it's taking place

  • Guangzhou, Guangdong, China
  • Nanning, Guangxi, China
  • Nanchang, Jiangxi, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Guangzhou, Guangdong, China; Nanning, Guangxi, China; Nanchang, Jiangxi, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.