IC Plus Low-dose Radiation Plus Cadonilimab in LANPC

NCT05941741 | Recruiting Phase 3 DMC

• 1 other identifier: Low-dose RT in NPC
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 3

Brief 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 (ICI) followed by concurrent chemoradiotherapy (CCRT) versus IC+CCRT, and compare the treatment-related adverse events and quality of life in two groups.

Conditions

Nasopharyngeal Carcinoma; Immune Checkpoint Inhibitor; Radiotherapy; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression free survival

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

  3 years

Secondary Outcomes (7)

• Overall survival

  3 years

• Local recurrence-free survival

  3 years

• Regional recurrence-free survival

  3 years

• Distant metastasis-free survival

  3 years

• Acute toxicities

  From the start of treatment until 3 months post treatment

Study Arms (2)

Low-dose RT plus ICI

EXPERIMENTAL

Patients will receive induction chemotherapy plus low-dose radiotherapy and immuce checkpoint inhibitor then followed by concurrent chemoradiotehrapy.

Radiation: Intensity Modulated Radiation Therapy; Drug: Chemotherapy; Biological: Immune checkpoint inhibitor; Radiation: Low-dose radiotherapy

IC+CCRT

ACTIVE COMPARATOR

Patients will receive induction chemotherapy plus concurrent chemoradiotehrapy.

Radiation: Intensity Modulated Radiation Therapy; Drug: Chemotherapy

Interventions

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.

Also known as: IMRT

IC+CCRT; Low-dose RT plus ICI

Chemotherapy DRUG

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

Also known as: Induction chemotherapy, Concurrent chemotherapy, Gemcitabine, Cisplatin

IC+CCRT; Low-dose RT plus ICI

Immune checkpoint inhibitor BIOLOGICAL

Cadonilimab: 10mg/kg, Q3W, 3 cycles

Also known as: Cadonilimab, AK104, PD-1/CTLA-4 inhibitor

Low-dose RT plus ICI

Low-dose radiotherapy RADIATION

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

Low-dose RT plus ICI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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);
• 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.

You may not qualify 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;
• Severe complication, eg, uncontrolled hypertension;
• Mental disorder;
• Drug or alcohol addition;
• Do not have full capacity for civil acts.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (3)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

NOT YET RECRUITING

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

NOT YET RECRUITING

Related Links

• Home Page of Cancer Center, Sun Yat-sen University

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Radiotherapy, Intensity-Modulated; Drug Therapy; Induction Chemotherapy; Gemcitabine; Cisplatin; Immune Checkpoint Inhibitors; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Therapeutics; Remission Induction; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Chong Zhao, MD, PhD

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chong Zhao, MD, PhD

CONTACT

02087342638; zhaochong@sysucc.org.cn

Jingjing Miao, MD

CONTACT

+8613631355201; miaojj@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: July 12, 2023
• Study Start: January 10, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)