Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06242067

Second-line Treatment of Metastatic Colorectal Cancer

Led by Qilu Hospital of Shandong University · Updated on 2024-02-05

50

Participants Needed

1

Research Sites

188 weeks

Total Duration

On this page

Sponsors

Q

Qilu Hospital of Shandong University

Lead Sponsor

T

The Affiliated Hospital of Qingdao University

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this multicenter, single-arm, observational cohort study is to investigate the efficacy and safety of irinotecan in combination with trifluridine-tipiracil and bevacizumab in colorectal cancer with prior oxaliplatin and fluoropyrimidine-based chemotherapy (including 5-FU/capecitabine/S-1) exposure in the metastatic setting or within 12 months of recurrence.

CONDITIONS

Official Title

Second-line Treatment of Metastatic Colorectal Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent before starting study procedures
  • Aged 18 to 75 years, any gender
  • ECOG performance status 0 to 1, life expectancy over 3 months
  • Histologically or cytologically confirmed metastatic or recurrent colorectal adenocarcinoma
  • Prior first-line treatment with fluoropyrimidine and oxaliplatin plus bevacizumab or cetuximab
  • Recurrence or metastasis within 12 months after adjuvant/neoadjuvant therapy with oxaliplatin and fluoropyrimidine
  • At least one measurable metastatic lesion per RECIST 1.1 criteria
  • Adequate bone marrow, kidney, and liver function within 7 days before treatment
  • Urine protein less than 1+ or 24-hour urine protein under 1 gram
  • INR or prothrombin time 1.5 times ULN or within range if on anticoagulant therapy
  • Female participants of child-bearing potential agree to use contraception during the study and for 90 days after last medication
Not Eligible

You will not qualify if you...

  • Prior first-line treatment with irinotecan
  • KRAS/NRAS/BRAF wild-type patients not treated with cetuximab in first line
  • Deficient mismatch repair or microsatellite instability-high status
  • Symptomatic brain or meningeal metastases except stable after local treatment over 6 months
  • Severe bleeding events within 3 months or coughing up fresh blood within 4 weeks
  • Recent cerebrovascular accident within 6 months
  • Unstable or severe cardiac conditions including low ejection fraction and arrhythmias
  • Uncontrolled hypertension above 140/90 mmHg
  • Digestive diseases or conditions that might affect drug absorption or cause bleeding
  • Second primary cancer within 5 years except certain skin or cervical cancers
  • Active infections including HIV, hepatitis B or C, or liver disease
  • Unresolved toxicities from prior therapy greater than grade 1 except alopecia
  • Any medical condition judged by investigator to make the patient unsuitable for the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Qilu hospital of Shandong University

Jinan, Shandong, China, 250012

Actively Recruiting

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Research Team

X

xiangling Wang, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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