Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma

Phase 3

Waitlist Available

Research Sponsored by Shanghai Zhongshan Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of first dosage to safety follow-up visit (30 days after the last dosage)

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

To evaluate of adjuvant therapy using oxaliplatin and gemcitabine (GEMOX regimen) versus capecitabine alone chemotherapy in patients who underwent curative surgery for intrahepatic cholangiocarcinoma (ICC) -- a randomized control study.

Eligible Conditions

Cholangiocarcinoma
Bile Duct Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of first dosage to safety follow-up visit (30 days after the last dosage)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of first dosage to safety follow-up visit (30 days after the last dosage)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first dosage to safety follow-up visit (30 days after the last dosage) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Other study objectives

Number of participants with adverse events and severe adverse events

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: GEMOXExperimental Treatment1 Intervention

oxaliplatin and gemcitabine (GEMOX regimen): day 1: oxaliplatin 85 mg/m2, gemcitabine 1000 mg/m2; day 8: gemcitabine 1000 mg/m2; every three weeks for 6-8 cycles in total.

Group II: CapecitabineActive Control1 Intervention

capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.

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