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Study on the predictive role and mechanism of tertiary lymphoid structure in neoadjuvant immunotherapy for locally advanced oral and oropharyngeal cancer

Study on the predictive role and mechanism of tertiary lymphoid structure in neoadjuvant immunotherapy for locally advanced oral and oropharyngeal cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500101942
Enrollment
Unknown
Registered
2025-05-06
Start date
2024-12-23
Completion date
Unknown
Last updated
2025-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral cancer and oropharyngeal cancer

Interventions

locally advanced patients:No intervention, observational study
Early and mid-stage patients:No intervention, observational study

Sponsors

Department of Stomatology, Second Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Signed and dated informed consent form for neoadjuvant treatment (with or without ICIs); 2. Age >= 18 years old, <75 years old; 3. Diagnosed as primary oral cancer or oropharyngeal cancer by the pathology department of our hospital; 4. Local early-to-mid stage oral cavity or oropharyngeal cancer refers to: T1-2NXM0, locally advanced stage refers to: T3-4NXM0, (tumor staging is based on the eighth edition of UICC TNM classification system) 5. The general condition is acceptable, there are no serious diseases of liver, kidney and other important organs, and there are no absolute contraindications for surgery; 6. For men of childbearing potential, use condoms or other methods to ensure that the sexual partner’s contraception is effective; 7. For women of childbearing potential, use highly effective contraceptive measures for at least one month before screening and agree to use this method for contraception during the study period.

Exclusion criteria

Exclusion criteria: 1. Previous cervical lymph node dissection; 2. Combined with primary immune system diseases, primary blood system diseases or primary malnutrition; 3. Taking traditional Chinese medicine or other drugs related to immune function and blood system; 4. Have received radiotherapy, chemotherapy, immunotherapy, targeted therapy and other tumor treatments for head and neck cancer in the past; 5. Unable to comply with experimental research procedures due to geographical, family, social or psychological reasons; 6. Known to be allergic to any of the study drugs involved or their preparation ingredients; 7. Pregnant women; 8. Surgery cannot cure the disease after preoperative induction chemotherapy.

Design outcomes

Primary

MeasureTime frame
Tertiary lymphatic structure;Tumor response rate;

Secondary

MeasureTime frame
One-year relapse free survival;

Countries

China

Contacts

Public ContactHaitao He

The Second Affiliated Hospital of Army Medical University

Jack_paul223@sina.com+86 135 0836 9133

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026