Skip to content

Phase Ia clinical trial of CPT injection

Phase Ia clinical trial of CPT injection

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-12002084
Enrollment
Unknown
Registered
2012-04-01
Start date
2005-04-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

lung cancer, colon cancer, lymphoma, multiple myeloma, etc.

Interventions

Sponsors

307th Hospital of People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients are diagnosed as lung cancer/ colon cancer in cytodiagnosis or tissue diagnosis; 2. With measurable lesions (except single dose); 3. KPS >= 70; 4. Aged >=18 when the consent is obtained; 5. Patients who are expected to survive for more than 3 months from the date of first administration; 6. In clinical examination be guaranteed as below: WBC >= 3.0*10^9/L, platelet >=75*10^9/L, hemoglobin >=9.5g/dLserum ALT/AST <=2.5 times upper limit of normal valueBUN/Cr <=1.5 times upper limit of normal valueTotal bilirubin with normal value (2.0-20.0umol /L); 7. HBV/HCV negative; 8. Patients who have not received pre-treatment more than 4 weeks before registration; 9. With written consent of the patient to participate in the trial; 10.The fertility in female patients with a negative pregnancy test.

Exclusion criteria

Exclusion criteria: 1. Patients with active infectious diseases or potential serious complications; 2. Pregnant women, or lactating women; 3. Patients with a previous history of serious allergy on study drugs(CPT protein, mannitol, SC, DSP, MSP); 4. Patients with pneumonia failure, heart failure, renal failure or liver failure; 5. Patients with poor compliance; 6. Patients could not describe the treatment response; 7. Patients that have participated in other clinical trials within 4 weeks before enrolled in the trial.

Design outcomes

Primary

MeasureTime frame
PK;DLT;MTD;AE;

Countries

China

Contacts

Public ContactSantai Song

307 hospital of People's Liberation Army

songsantai2006@163.com+86 010 66947588

Outcome results

None listed

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