Study of Lobaplatin,5-Fluorouracil and Leucovorin for the Treatment of Esophageal Carcinoma


Taian Cancer Hospital

Status and phase

Phase 3


Esophageal Carcinoma


Drug: lobaplatin , 5-FU ,leucovorin

Study type


Funder types




Details and patient eligibility


The purpose of this study is to evaluate the efficacy and the toxicity of lobaplatin, 5-fluorouracil (5-FU) and leucovorin in patients with esophageal carcinoma.

Full description

patients with metastatic or recurrent esophageal cancer have a particularly poor prognosis .The overall 5-year survival rate for patients with newly diagnosed esophageal cancer is under 10%. Metastatic esophageal carcinoma is an incurable disease and due to the lack of effective therapies to manage this disease,the median survival is only 6 to 8 months Chemotherapy which is one of the most effective treatment so far is used as part of combined modality therapy for locally advanced diseases or as a palliative treatment for metastatic diseases.Lobaplatin is the third generation of platinum.Phase Ⅱclinical trials indicate that lobaplatin is effective for esophageal cancer, ovarian cancer, breast cancer and small cell lung cancer.


120 estimated patients




18 to 65 years old


No Healthy Volunteers

Inclusion criteria

  • Histologically proven squamous cell carcinoma of the esophagus(include cardiac cancer)
  • Newly diagnosed patients should be unable or unwilling to surgery
  • Recurrence after surgery must have no adjuvant chemotherapy or radiotherapy are allowed
  • Patients are required to have dimensionally measurable disease,with an objective measurable focus:preferably the use of spiral computed tomography(CT)and measurements of maximum diameter≥1cm.
  • Cooperative Oncology Group performance status 0-2 or KPS score ≥60,survival time ≥3 months
  • Neutrophils(ANC)≥1.5×109/L; blood platelets counts(BPC)≥80×109/L
  • Hemoglobin(Hgb)≥90g/L ,serum total bilirubin ≤1.0 times the upper normal limit(ULN): alanine aminotransferase and glutamic-oxalacetic transaminase (ALT and AST)≤2.5 ULN
  • Serum creatinine (Cr)≤1.5ULN

Exclusion criteria

  • pregnant or nursing women;
  • Female patients at child-bearing age, without taking effective contraceptive methods;
  • patients who have pathologic confirmation of other types of tumors (eg, leiomyosarcoma, malignant lymphoma) rather than esophageal cancer;
  • patients with tumors other than esophageal cancer ,except cervical carcinoma in situ and skin basal cancer or squamous cell carcinoma received adequate treatment;
  • patients with cerebral or meningeal metastasis, intestinal obstruction, or symptomatic pathologic changes of peripheral nerve,NCIC-CTG standard >grade 2
  • patients with serious complications such as: serious heart disease remained unstable after treatment, or myocardial infarction, congestive heart failure, unstable angina, frank pericardial effusion or unstable arrhythmias in 6 months before being enrolled into the group; confirmed neuropathy or psychosis, including dementia or epilepsia; uncontrolled infection;active disseminated intravascular coagulation;uncontrolled diabetes, fasting serum glucose> 7.8mmol / L

Trial design

Primary purpose




Interventional model

Single Group Assignment


None (Open label)

120 participants in 1 patient group

Esophageal Carcinoma
Experimental group
Drug: lobaplatin , 5-FU ,leucovorin

Trial contacts and locations



Data sourced from

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