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Anti-metabolites

Trifluridine/Tipiracil for Cholangiocarcinoma (MOCHA Trial)

Phase 2
Waitlist Available
Research Sponsored by Sunnybrook Health Sciences Centre
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 enrolment until the date of objective radiological disease progression according to recist v1.1 or death (by any cause in the absence of progression) up to 1 year
Awards & highlights

MOCHA Trial Summary

This trial is studying a new cancer treatment and will enroll 47 patients over 12 months.

Eligible Conditions
  • Cholangiocarcinoma
  • Bile Duct Cancer

MOCHA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrolment until the date of objective radiological disease progression according to recist v1.1 or death (by any cause in the absence of progression) up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrolment until the date of objective radiological disease progression according to recist v1.1 or death (by any cause in the absence of progression) up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median progression-free survival (PFS)
Secondary outcome measures
Disease Control Rate (Complete Response, Partial Response, Stable Disease) of FTD/TPI
Duration of response of FTD/TPI
Median overall survival of patients with cholangiocarcinoma treated with FTD/TPI.
+2 more

Side effects data

From 2023 Phase 3 trial • 492 Patients • NCT04737187
62%
Neutropenia
37%
Nausea
28%
Anaemia
24%
Asthenia
22%
Fatigue
21%
Diarrhoea
20%
Decreased appetite
18%
Vomiting
17%
Thrombocytopenia
14%
Neutrophil count decreased
11%
Constipation
11%
Stomatitis
11%
Abdominal pain
10%
Hypertension
9%
Abdominal pain upper
9%
Platelet count decreased
9%
Aspartate aminotransferase increased
9%
Alanine aminotransferase increased
8%
Weight decreased
8%
Headache
7%
Leukopenia
7%
Arthralgia
7%
Back pain
6%
Proteinuria
5%
Blood bilirubin increased
5%
Pyrexia
3%
Intestinal obstruction
2%
Malignant neoplasm progression
2%
COVID-19
1%
Hyperbilirubinaemia
1%
Acute kidney injury
1%
Biliary dilatation
1%
Large intestinal obstruction
1%
Stoma site haemorrhage
1%
Septic shock
1%
Metastases to meninges
1%
Jaundice
1%
Bile duct stenosis
1%
Cholangitis
1%
Jaundice cholestatic
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trifluridine/Tipiracil + Bevacizumab
Trifluridine/Tipiracil

MOCHA Trial Design

1Treatment groups
Experimental Treatment
Group I: Trifluridine/TipiracilExperimental Treatment1 Intervention
FTD/TPI at 35 mg/m2 (based on BSA) that is administered in tablet form, orally, twice daily, within one hour of morning and evening meals, on days 1-5 and days 8-12 of a 28 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tipiracil
FDA approved

Find a Location

Who is running the clinical trial?

Taiho Pharma Canada, Inc.UNKNOWN
Taiho Oncology, Inc.Industry Sponsor
66 Previous Clinical Trials
11,576 Total Patients Enrolled
5 Trials studying Cholangiocarcinoma
807 Patients Enrolled for Cholangiocarcinoma
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,550,614 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma
2019. "Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04076761.
~1 spots leftby Apr 2025
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