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Sorafenib Combined With Cisplatin and Gemcitabine for the Treatment of Patients With Advanced Renal Collecting Duct Carcinoma:A Pilot, Open Study

Phase 2
18 Years
70 Years
Open (Enrolling)
Renal Cell Carcinoma

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Trial Information

Sorafenib Combined With Cisplatin and Gemcitabine for the Treatment of Patients With Advanced Renal Collecting Duct Carcinoma:A Pilot, Open Study

Collecting duct carcinoma(CDC) of the kidney is a rare and aggressive neoplasm of the distal
collecting tubules for which there is no established treatment. Since the histology of
collecting duct carcinoma is similar to that of urothelial carcinoma, a prospective phase II
trial in France(2007) studied gemcitabine plus cisplatin as the first-line treatment of
advanced CDC, resulting an effective rate of 26%. The targeted drugs can produce definite
efficacy on renal clear cell carcinoma, but the data on targeted drugs for the treatment of
renal advanced collecting duct carcinoma is limited. We sponsored this study based on the
assumption that targeted drugs combined with chemotherapy can produce additive, positive
effects in CDC.

Inclusion Criteria:

- Age≥18 years, ≤70 years, male or female;

- Advanced collecting duct carcinoma of the kidney is diagnosed histologically or
pathologically ;

- Have not received anti-angiogenesis targeted drug therapy and systemic chemotherapy;

- Have at least one measurable tumor lesion (Response Evaluation Criteria In Solid

- Eastern Cooperative Oncology Group(ECOG) performance scale is 0 or 1;

- The expected life span is ≥12 weeks;

- No contraindications for chemotherapy, with enough liver function and renal function
and normal ECG recording.Peripheral hemogram: neutrophil≥1.5×109/L, Plt≥100×109/L,
Hgb≥90 g/L;Renal function: serum creatinine≤1.5 folds the upper limit of normal
(ULN); For patients with non-metastatic liver dysfunction: alanine aminotransferase
and aspartate aminotransferase≤2.5 ULN, For patients with metastatic liver
dysfunction: alanine aminotransferase and aspartate aminotransferase≤5 ULN;

- The patients participate voluntarily and have signed the informed consent form.

Exclusion Criteria:

- Pregnant and lactating women, or female patients of child-bearing age without taking
contraceptive measures;

- Patients with severe acute infection without being controlled effectively or having
pyogenic and chronic infections with persistently unhealed wounds;

- Past history of serious heart diseases, including: cardiac function classification
≥NYHA class II, unstable angina pectoris, myocardial infarction, arrhythmia requiring
anti-arrhythmic drug therapy (excluding β-blockers or digoxin), and uncontrolled

- Patients with a history of HIV infection or active phase of chronic hepatitis B/C;

- negative imaging examination result 4 weeks prior to enrollment);

- Epilepsy patients requiring drug therapy (e.g. steroids or antiepileptic drugs);

- A history of allogeneic organ transplantation;

- Patients with evidence of hemorrhagic constitution or a past history of hemorrhage;

- Patients currently receiving renal dialysis;

- Past or present concomitant tumors with the primary lesions or histological
characteristics different from the tumors evaluated in this study, excluding other
tumor cured longer than 3 years before enrollment;

- Patients participating in other clinical trials simultaneously;

- Other conditions unsatisfying the inclusion criteria in the investigator's opinions.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progress-free survival,PFS

Outcome Description:

Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause.

Outcome Time Frame:

Time from enrollment to the dates of disease progression,death from any cause or last tumor assessment reported between date of first patient enrollment until 30 June 2015 cut of date

Safety Issue:


Principal Investigator

Jun Guo, MD,PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beijing Cancer Hospital


China: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

September 2015

Related Keywords:

  • Renal Cell Carcinoma
  • advanced,renal cell carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal