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A Clinical Study in Three-arm of Sodium Cantharidate with or without Docetaxel vs Docetaxel alone as Second Line Treatment in Advanced Squamous Lung Cancer

A Clinical Study in Three-arm of Sodium Cantharidate with or without Docetaxel vs Docetaxel alone as Second Line Treatment in Advanced Squamous Lung Cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16009159
Enrollment
Unknown
Registered
2016-09-05
Start date
2016-09-01
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

Advanced Squamous Lung Cancer

Interventions

Combined therapy:Sodium Cantharidate+Docetaxel
Chemotherapy:Docetaxel
Sodium Cantharidate:Sodium Cantharidate

Sponsors

the 2nd Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed squamous lung cancer; 2. ECOG Performance Status 0-2; 3. relapse or failure of one first line prior chemotherapy; 4. No previous treatment with Docetaxel; 5. Measurable Disease; 6. Brain metastases that have been treated with radiotherapy should be stable and asymptomatic; 7. life expectancy of at least 12 weeks; 8. Adequate liver kidney and bone marrow function; 9. Patients must be able to understand the nature of this study and give written informed consent; 10. male or female patient aged 18 to 75 years old.

Exclusion criteria

Exclusion criteria: 1. active brain metastases or leptomeningeal disease; 2. treatment with other investigational drugs or other anti-cancer therapy or treatment in another clinical trial within the past four weeks before start of - therapy or concomitantly with this trial; 3. preexisting ascites and/or clinically significant pleural effusion; 4. serious illness or concomitant non-oncological disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration; 5. Women who are pregnant or lactating; 6. active alcohol or drug abuse; 7. Serious neurologic or psychiatric disease; 8. Second primary malignancy within the past 5 years, except nonmelanomas skin cancer or in situ carcinoma of the cervix; 9. Active uncontrolled infection; 10. history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80 (Tween 80); 11. hypersensitivity to Sodium Cantharidate and/or the excipients of the trial drugs; 12. Attending other clinical trials in past 4 weeks.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
OS;N-4GAE-PFS;DCR;TDS;QOL;AE;

Countries

China

Contacts

Public ContactChunhong Hu

the 2nd Xiangya Hospital of Central South University

huchunh5829@126.com+86 0731-85295829

Outcome results

None listed

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