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NCT Number: NCT05941741

IC Plus Low-dose Radiation Plus Cadonilimab in LANPC

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Intensity modulated radiation therapy

Radiation

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.

Other names: IMRT

Chemotherapy

Drug

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

Other names: Induction chemotherapy, Concurrent chemotherapy, Gemcitabine, Cisplatin

Immune checkpoint inhibitor

Biological

Cadonilimab: 10mg/kg, Q3W, 3 cycles

Other names: Cadonilimab, AK104, PD-1/CTLA-4 inhibitor

low-dose radiotherapy

Radiation

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

Primary outcomes

  1. Progression free survival

    Time frame: 3 years

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

Secondary outcomes

  1. Overall survival

    Time frame: 3 years

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

  2. Local recurrence-free survival

    Time frame: 3 years

    From the date of randomization to local recurrence or any death

  3. Regional recurrence-free survival

    Time frame: 3 years

    From the date of randomization to regional recurrence or any death

  4. Distant metastasis-free survival

    Time frame: 3 years

    From the date of randomization to distant metastasis or any death

  5. Acute toxicities

    Time frame: From the start of treatment until 3 months post treatment

    Assessed with CTCAE v5.0

  6. Late toxicities

    Time frame: 3 years post treatment

    Assessed with RTOG/EORTC

  7. Quality of life score

    Time frame: Through study completion, an average of 3 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Chong Zhao, MD, PhD

CONTACT

[email protected]

02087342638

Jingjing Miao, MD

CONTACT

[email protected]

+8613631355201

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Jul 12, 2023
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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