Skip to content

Clinical study of patients with advanced lung cancer and colorectal cancer with new antigens based on tumor neogens

Clinical study of patients with advanced lung cancer and colorectal cancer with new antigens based on tumor neogens

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073417
Enrollment
Unknown
Registered
2023-07-11
Start date
2023-04-28
Completion date
Unknown
Last updated
2023-07-16

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

Conditions

Lung cancer, colorectal cancer

Interventions

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of lung and colorectal cancer. 2. Diagnosis of metastatic cancer by pathology laboratory. 3. The subjects experienced postoperative recurrence or disease progression after 2 cycles of two standard or conventional first-line protocols, and continued use of the existing treatment could not benefit the patients better. 4. The subject receives at least one first-line treatment and the disease progresses, and the subject cannot tolerate or refuses to receive other conventional treatments. 5. Exclude subjects with brain metastases. 6. The subject of radiochemical therapy must be clinically stable one month after treatment to meet the needs of the subject. 7. At least 18 years old and at least 70 years old. 8. Clinical manifestations ECOG 0, 1, 2. 9. Serological test: seronegative of HIV antibodies (experimental treatment in this protocol depends on the integrity of the immune system. Hiv-seropositive subjects have reduced immune capacity and poor response to experimental treatment); Sera negative for hepatitis B antigen, sera negative for hepatitis C antibody; Serum ALT/AST is less than or equal to 2.5 times the upper limit of normal, serum creatinine is less than or equal to 1.6mg/dl, and total bilirubin is less than or equal to 1.5mg/ dl, but subjects with Gilbert syndrome must have total bilirubin below 3.0mg/ dl. 10. Hematology: Without the support of granulocyte colony stimulating factor, absolute neutrophil count =1×10^9 /L, white blood cell count =3×10^9/L, platelet count =100×10^9/L, hemoglobin > 8.0g /dl, CD4+ cell count > 200 /µL. 11. By the time the patient receives the vaccine, the subject's other therapeutic drug toxicity must have returned to grade 1 or less (except for toxicity such as baldness or vitiligo). Note: The patient may have undergone minor surgical procedures in the past 3 weeks, as long as all toxic reactions return to grade 1 or less. 12. Presurvival =6 months. 13. Able to understand and willing to sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. primary immunodeficiency in any form (e.g., severe combined immunodeficiency disease); 2. Concurrent opportunistic infection. Immunocompromised subjects were slow to respond to experimental treatments; 3. Active systemic infection (e.g. need anti-infective treatment), blood clotting disorder or any other serious disease; 4. Poor general condition (ECOG=2), estimated to be unable to tolerate short-term chemotherapy and immune cell therapy; 5. Is receiving systemic glucocorticoid therapy; 6. Unstable angina pectoris, symptomatic congestive heart failure, severe arrhythmia, myocardial infarction in the past 6 months, prolonged QT interval (> 450 ms); 7. Malignant tumors of other sites have appeared within the last 5 years. Subjects cannot be followed up or are participating in other clinical trials; 8.The investigator determined that the subjects were not suitable for participating in the study for other reasons.

Design outcomes

Primary

MeasureTime frame
The incidence and severity of treatment-related adverse events; ;Treatment response rate;Overall survival;

Secondary

MeasureTime frame
PFS;AFP?PIVKA-II?CA199?CEA?CA724 and other tumor markers;PCR was used to detect the survival of neoantigen personalized DC cells;

Countries

China

Contacts

Public ContactGuoqing Lv

Peking University Shenzhen Hospital

365973269@qq.com+86 135 1033 3122

Outcome results

None listed

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