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Investigation on genomic biomarkers that negatively correlated with the clinical responses of immunotherapy

Investigation on genomic biomarkers that negatively correlated with the clinical responses of immunotherapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100052367
Enrollment
Unknown
Registered
2021-10-24
Start date
2021-11-01
Completion date
Unknown
Last updated
2023-01-16

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

Conditions

Primary inoperable or advanced non-small cell lung cancer

Interventions

Serious adverse reaction group:Liquid biopsy or puncture biopsy
hyperprogressive group:Liquid biopsy or puncture biopsy
No serious adverse reactions or no super-progression group:Liquid biopsy or puncture biopsy

Sponsors

The General Hospital of the People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Able to provide written informed consent, and understand and agree to follow the research requirements; 2. Men or women over 18 years old; 3. Histopathologically diagnosed as the following cancer types, and received corresponding treatment: (1) Newly treated inoperable or advanced NSCLC patients: driver gene-negative lung adenocarcinoma; PD-1 monotherapy/PD-1 combined with pemetrexed + platinum therapy; lung squamous cell carcinoma: PD-1 Monotherapy/PD-1 combined with taxane + platinum therapy; (2) Newly treated SCLC (limited/extensive) patients: receive PD-L1 combined with etoposide + platinum therapy; (3) Metastatic esophageal squamous cell carcinoma: receive PD-1 combined with taxane/fluorouracil+platinum in the initial treatment or in the later line; (4) Metastatic urothelial carcinoma: receive PD-1 combined with taxane/gemcitabine+platinum for initial treatment or later line; (5) Advanced gastric cancer: receive PD-1/L1 combined with taxane/fluorouracil+platinum in the initial treatment or in the later line; (6) Advanced colorectal cancer: receive PD-1/L1 combined with FOLFOX/XELOX for initial treatment or later line; (7) Advanced cholangiocarcinoma: receive PD-1/L1 combined with taxane + platinum in the initial treatment or in the later line; (8) Advanced soft tissue sarcoma: receive PD-1/L1 single agent/PD-1/L1 combined with axitinib in the initial treatment or in the later line; 4. ECOG performance status = 6 months; 7. The patient must have sufficient organ function, and the following laboratory test values ??are required 7 days before treatment: (1) Absolute neutrophil count (ANC) >=1.5x10^9/L, platelets >=100x10^9/L, hemoglobin >=90g/L; (2) Remarks: The patient must not receive blood transfusion or growth factor support within 14 days before blood sample collection; (3) International normalized ratio (INR) or prothrombin time <= 1.5xULN; (4) Activated partial thromboplastin time (aPTT)<=1.5xULN; (5) Serum total bilirubin<=1.5xULN (patients with Gilbert syndrome can be enrolled if total bilirubin <3xULN); (6) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5xULN, if the patient has liver metastases, this standard is AST and ALT <= 5xULN.

Exclusion criteria

Exclusion criteria: 1. The patient has received blood transfusion within three months; 2. The patient has immune system deficiency; 3. Pregnant patients; 4. Patients with alcohol or drug addiction; 5. Other researchers believe that it may affect the experimental results or be unethical.

Design outcomes

Primary

MeasureTime frame
Tumor growth rate;

Secondary

MeasureTime frame
time to progress;

Countries

China

Contacts

Public ContactHu Yi

PLA General Hospital

huyi0401@aliyun.com+86 13911031186

Outcome results

None listed

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