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Nasopharyngeal CarcinomaPhase 3NCT05941741

IC Plus Low-dose Radiation Plus Cadonilimab in LANPC

A Phase 3 study testing Intensity Modulated Radiation Therapy, Chemotherapy and Immune checkpoint inhibitor in people with Nasopharyngeal Carcinoma and Immune Checkpoint Inhibitor, run by Sun Yat-sen University at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Intensity Modulated Radiation Therapy, Chemotherapy and Immune checkpoint inhibitor
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
380 participants
Where
3 sitesChina
Study dates
10 Jan 2024to Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
  • Sign the consent form.

Who cannot join

  • 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;
Show all 10Show fewer
  • Severe complication, eg, uncontrolled hypertension;
  • Mental disorder;
  • Drug or alcohol addition;
  • Do not have full capacity for civil acts.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chong Zhao, MD, PhD contact

02087342638

zhaochong@sysucc.org.cn

Jingjing Miao, MD contact

+8613631355201

miaojj@sysucc.org.cn

China3 sites, 3 recruiting

  • Cancer Center, Sun Yat-sen University

    Guangzhou, Guangdong

    Chong Zhao, M.D, 02087342638, zhaochong@sysucc.org.cn

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi

    Jingao Li

    Not yet recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Min Kang, MD

    Not yet recruiting

Other trials in China

About this study

Official title: Induction Chemotherapy Combined With Low-dose Radiation Plus Cadonilimab in Loco-regionally Advanced Nasopharyngeal Carcinoma: a Multi-center, Open-label, Randomized Controlled Phase III Clinical Trial

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.

Being tested
Intensity Modulated Radiation Therapy, Chemotherapy, Immune checkpoint inhibitor, Low-dose radiotherapy
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensity Modulated Radiation TherapyRadiation

    Also called IMRT

    All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node), 60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions.

  • ChemotherapyDrug

    Also called Induction chemotherapy, Concurrent chemotherapy, Gemcitabine, Cisplatin

    Induction chemotherapy: gemcitabine and cisplatin, Q3W, 3 cycles Concurrent chemotherapy: cisplatin, Q3W, 2-3 cycles

  • Immune checkpoint inhibitorBiological

    Also called Cadonilimab, AK104, PD-1/CTLA-4 inhibitor

    Cadonilimab: 10mg/kg, Q3W, 3 cycles

  • Low-dose radiotherapyRadiation

    Low-dose radiotherapy will be performed to study group, with the use of IMRT.

Study groups in NCT05941741
Study groupRoleWhat they receive
Low-dose RT plus ICIExperimentalPatients will receive induction chemotherapy plus low-dose radiotherapy and immuce checkpoint inhibitor then followed by concurrent chemoradiotehrapy.
Receives: Radiation: Intensity Modulated Radiation Therapy; Drug: Chemotherapy; Biological: Immune checkpoint inhibitor; Radiation: Low-dose radiotherapy
IC+CCRTActive comparatorPatients will receive induction chemotherapy plus concurrent chemoradiotehrapy.
Receives: Radiation: Intensity Modulated Radiation Therapy; Drug: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    From the date of randomization to local or regional recurrence, distant metastasis or any death

    Measured: 3 years

Secondary outcomes (7)

  1. Overall survival

    From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up

    Measured: 3 years

  2. Local recurrence-free survival

    From the date of randomization to local recurrence or any death

    Measured: 3 years

  3. Regional recurrence-free survival

    From the date of randomization to regional recurrence or any death

    Measured: 3 years

  4. Distant metastasis-free survival

    From the date of randomization to distant metastasis or any death

    Measured: 3 years

  5. Acute toxicities

    Assessed with CTCAE v5.0

    Measured: From the start of treatment until 3 months post treatment

  6. Late toxicities

    Assessed with RTOG/EORTC

    Measured: 3 years post treatment

  7. Quality of life score

    Assessed with EORTC-Quality of life questionnaire-C30 version 3.0

    Measured: Through study completion, an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2023
  2. Study start10 Jan 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05941741
Sponsor's protocol ID
Low-dose RT in NPC
Status last verified
May 2026
First submitted
1 Jul 2023
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intensity Modulated Radiation Therapy, Chemotherapy and Immune checkpoint inhibitor in people with Nasopharyngeal Carcinoma and Immune Checkpoint Inhibitor, run by Sun Yat-sen University at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chong Zhao, MD, PhD (02087342638, zhaochong@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05941741.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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