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Study of intravenous recombinant human lymphotoxin-a derivative (rhLTa-Da) conbined with cisplatin and 5-Fluorouracil in recurrent and metastatic esophageal cancer

Study of intravenous recombinant human lymphotoxin-a derivative (rhLTa-Da) conbined with cisplatin and 5-Fluorouracil in recurrent and metastatic esophageal cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001197
Enrollment
Unknown
Registered
2011-02-15
Start date
2011-03-01
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

Late-stage esophageal cancer

Interventions

Group A:Low-dose LT+PF
Group B:High-dose LT+PF
Group C:PF

Sponsors

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-70 years; 2. Diagnosed as esophageal cancer by pathology or cytology, and haven't received the palliative chemotherapy or relapse in half a year after the neo-adjuvant chemotherapy/ adjuvant chemotherapy; 3. With at least on evaluable focus according to RESICT1.1 standard. 4. Without the cardiovascular, hepatic, renal and hematopoietic disorder; 5. Karnofsky scores (KPS) >=70; 6. Predicted survival time>3 months; 7. Signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Participate in other trials meanwhile; 2. Complicated with other malignant tumor; 3. Allergic to cisplatin and 5-fluorouracil; 4. Pregnant or breast-feeding women; 5. Refuse to the contraception.

Design outcomes

Primary

MeasureTime frame
PFS;ORR;

Secondary

MeasureTime frame
DCR;OS;

Countries

China

Contacts

Public ContactWenqi Jiang, Yuhong Li
liyh@sysucc.org.cn+86 20 87343486

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 1, 2026