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An Pilot Study of S-1 Combined With Oxaliplatin for First-line Treatment of Unresectable, Metastatic or Locally Advanced Biliary Tract Cancer or Ampullary Adenocarcinoma

Phase 2
18 Years
74 Years
Not Enrolling
Biliary Tract Cancer

Thank you

Trial Information

An Pilot Study of S-1 Combined With Oxaliplatin for First-line Treatment of Unresectable, Metastatic or Locally Advanced Biliary Tract Cancer or Ampullary Adenocarcinoma

To list in cases with unresectable, metastatic or locally advanced biliary tract or
ampullary adenocarcinoma that have not been treated before,confirm the efficacy and safety
of combined S-1/L-OHP regimen for the biliary tract or ampullary carcinoma, providing
evidence-based proof for the future treatment.

Inclusion Criteria:

1. Informed consent has been signed by the subject itself;

2. Aged over 18;

3. With a definite pathological or cytological diagnosis of adenocarcinoma;

4. No pre-treatment (including radiotherapy, chemotherapy, immunotherapy, etc.). For
recurrent cases, if the subjects have received adjuvant chemotherapy without S-1 or
L-OHP after surgery and the time to the end date of adjuvant chemotherapy is over 6
months, they can also be enrolled;

5. Enhanced helical CT or MRI scanning shows a target lesion over 1cm within 14 days
before enrollment

6. Within 7 days before enrollment, baseline blood routine and biochemical indicators
meet the following criteria:

- Hemoglobin ≥ 90g/L,

- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L,

- Platelets ≥ 100×109/L,

- Serum total bilirubin < 1.5 times of the upper normal limit,

- Serum creatinine < upper limit of normal,

- Serum albumin ≥ 30 g/L;

7. Can receive oral administration;

8. Karnofsky(KPS) score ≥ 70 points;

9. Expected survival time is more than 90 days;

10. Women of childbearing age must receive urine or blood pregnancy test within 7 days
before randomization and the results are negative;

11. Male and female patients of appropriate reproductive age are willing to use reliable
contraception methods for contraception in the process of study till 30 days after
drug withdrawal.

Exclusion Criteria:

1. Patients with a severe drug allergy history (including mildly allergic to L-OHP,
5-FU, FT207, 5-HT3 receptor antagonist);

2. Patients who participated or are participating in other clinical trials within 4
weeks before enrollment;

3. Patients who have received blood transfusion, blood products and hematopoietic factor
preparations such as G-CSF within 15 days before enrollment;

4. Patients who have undergone a surgery within 15 days before enrollment, and its
effects have not been eliminated;

5. Patients with diarrhea;

6. Patients with a complication of active infection (infection causes a fever above 38

7. Patients accompanied by dysphagia, complete or incomplete gastrointestinal
obstruction, active gastrointestinal bleeding and perforation, etc. that cause
difficulty in taking S-1 orally;

8. Patients with severe liver disease (e.g. active hepatitis, cirrhosis, etc.), renal
insufficiency, severe lung disease (interstitial pneumonia, pulmonary fibrosis,
severe emphysema, etc.), or uncontrollable diabetes, hypertension and other chronic
systemic diseases;

9. Patients who have received long-term systemic steroid therapy (Note: short-term users
with steroid withdrawal > 2 weeks can be selected);

10. Patients with brain metastases or suspected of brain metastases;

11. Patients with peripheral nervous system disorder or a history of significant mental
disorder and central nervous system disorder;

12. Heart disease of significant clinical symptoms, e.g. congestive heart failure,
coronary heart disease with significant symptoms, arrhythmia and hypertension that
are difficult to be controlled by drugs, or with an episode of myocardial infarction
within 6 months, or cardiac insufficiency;

13. Patients with pleural effusion, ascites, or pericardial effusion that needs drainage;

14. Pregnant or breast-feeding women, or male and female patients of appropriate
reproductive age who refuse to take contraceptive measures;

15. Patients who have suffered from other malignancies within 5 years, except basal cell
carcinoma and carcinoma in situ of uterine cervix that have already been cured;

16. Patients without legal capability, or who can not continue the study due to medical
or ethical reasons;

17. Patients who are determined not suitable to participate in this clinical trial by the

Type of Study:


Study Design:

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

Outcome Measure:

objective response rate

Outcome Description:

to evaluate objective response rate (ORR) of SOX regimen to BTC (Ampullary Adenocarcinoma)

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Lin Shen, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beijing Cancer Hospital


China: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

August 2012

Related Keywords:

  • Biliary Tract Cancer
  • 40 S-1/L-OHP
  • biliary tract
  • ampullary carcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Biliary Tract Neoplasms