NCT05004831

Brief Summary

This phase II study aims to explore the efficacy and safety of fruquintinib combined with TAS-102 in the third-line treatment of patients with advanced metastatic colorectal cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

March 11, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

1.5 years

First QC Date

August 6, 2021

Last Update Submit

August 17, 2022

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • PFS

    Progression-free Survival

    from randomization up to progressive disease or EOT due to any cause, up to 2 years

Secondary Outcomes (4)

  • OS

    from randomization until death due to any cause, assessed up to 3 years

  • DCR

    from randomization up to progressive disease or EOT due to any cause, up to 2 years

  • ORR

    from randomization up to progressive disease or EOT due to any cause, up to 2 years

  • Safety and tolerance

    from first dose to within 30 days after the last dose

Study Arms (1)

fruquintinib plus TAS-102

EXPERIMENTAL

fruquintinib plus TAS-102, orally given, Q4W

Drug: fruquintinib plus TAS-102

Interventions

fruquintinib plus TAS-102DRUG

fruquintinib 4mg/d, qd po, D1-21, Q4W; TAS-102 70mg/m2/d, bid po, D1-5, 8-12, Q4W

fruquintinib plus TAS-102

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 and ≤ 75 years of age;
  • Histological or cytological confirmed advanced metastatic colorectal cancer;
  • Refractory to at least second line standard treatment containing fluorouracil, oxaliplatin and irinotecan;
  • At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan or 20mm by conventional CT scan);
  • ECOG performance status of 0-1;
  • Life expectancy ≥ 12 weeks;
  • No previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitor (TKI);
  • Signed and dated informed consent;
  • Adequate hepatic, renal, heart, and hematologic functions;
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

You may not qualify if:

  • Pregnant or lactating women;
  • Any factors that influence the usage of oral administration or any disease or condition that affects drug absorption;
  • Previous treatment with TAS-102;
  • Participated in clinical trials of other drugs within four weeks before enrollment;
  • Received other systemic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy;
  • International normalized ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \> 1.5 × ULN;
  • Clinically significant electrolyte abnormalities;
  • Subjected with hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg;
  • Unrelieved toxic reactions higher than CTCAE V5.0 grade 1 caused by any previous anti-cancer treatment;
  • Incomplete healing of skin wound, surgical site, traumatic site, severe mucosal ulcer or fracture;
  • Conditions that may cause gastrointestinal bleeding and perforation determined by the researcher;
  • History of arterial thrombosis or deep venous thrombosis within 6 months before enrollment;
  • Stroke and / or transient cerebral ischemia occurred within 12 months before enrollment;
  • Cardiovascular diseases with significant clinical significance;
  • LVEF\<50%;
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the first affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

HMPL-013trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jianjun Peng, M.D.

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianjun Peng, M.D.

CONTACT

+8613602263939pjianj@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 13, 2021

Study Start

March 11, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2024

Last Updated

August 18, 2022

Record last verified: 2022-08

Locations

CN(1)