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Therapeutic cancer vaccine: Phase I clinical tolerance study of hu-rEGF-rP64k/Mont in patients with advanced Non-Small Cell Lung Cancer

Therapeutic cancer vaccine: Phase I clinical tolerance study of hu-rEGF-rP64k/Mont in patients with advanced Non-Small Cell Lung Cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OID-17014048
Enrollment
Unknown
Registered
2017-12-20
Start date
2012-04-11
Completion date
Unknown
Last updated
2018-01-29

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

Conditions

Non-Small Cell Lung Cancer

Interventions

Case series:EGF Vaccine

Sponsors

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult patients, regardless of gender, aged from 18 to 70 years with histologically or cytologically confirmed NSCLC at stages IIIB or IV; 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2; 3. All patients received 4 to 6 cycles of platinum-based first-line chemotherapy, from 4 to 8 weeks, and were evaluated as SD or PR after the first line chemotherapy; 4. Patients were required to have at least 1 measurable lesion (lesions were defined by Response Evaluation Criteria in Solid Tumors (RECIST, 1.1). If patients have ever received radiotherapy, the disease in the field of radiotherapy cannot be the target lesions; 5. Adequate organ function and CBC results; 6. Life expectancy of at least 3 months; 7. Women participants should have negative pregnancy test results; 8. All the participants should take contraception measures during the study period; 9. Participants should sign informed consent before the study.

Exclusion criteria

Exclusion criteria: 1. Patients receiving immunosuppressant drugs 1 month before study or receiving other immunotherapy 3 months before; 2. Patients receiving corticosteroid within 1 month before the research (including oral, intramuscular or intravenous injection). Inhaled corticosteroid for for respiratory insufficiency or for local use were not excluded; 3. Patients with uncontrolled epilepsy seizure, central nervous system dysfunction or cognitive ability lose due to psychosis; 4. Patients with CNS metastasis (confirmed or suspicious); 5. Patients with chronic alcohol or drug abuse within 6 months before the research; 6. Patiens who are pregnant or lactating or those who refused to take contraception measures during the study were excluded; 7. Patients with a history of severe allergy or allergic constitution; splenectomy; 8. Patients with autoimmune disease or secondary immunodeficiency (such as AIDS, et al); 9. Patients with secondary malignancy within 5 years (except for basal cell carcinoma of the skin or intraepithelial carcinoma of the cervix) were also excluded.

Design outcomes

Primary

MeasureTime frame
maximum-tolerated dose;antiEGF antibodies detection;Serum EGF concentration;

Secondary

MeasureTime frame
Clinical response evaluation;

Countries

China

Contacts

Public ContactShi Yuankai

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences

syuankai@cicams.ac.cn+86 13701251865

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 7, 2026