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Completed

NCT Number: NCT06031376

Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC

Fruquintinib with PD-1 inhibitors (FP) and TAS-102 with bevacizumab (TB) are two common therapies for patients with previous-treated metastatic colorectal cancer (mCRC). However, it's still not clear that which therapy can bring better prognosis. Our study sought to investigate the efficacy and safety of fruquintinib with PD-1 Inhibitors versus TAS-102 with bevacizumab in Late-Line mCRC between July 2019 to October 2022July 2019 and June 2021 at the Hunan Cancer Hospital.

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Key information

About this study

This is a retrospective cohort study conducted in Hunan Cancer Hospital. Patients (pts) with mCRC who had received at least the 2nd line treatment were eligible. Propensity score (PS) would be calculated to balance the baseline characteristics of two arms. Overall survival (OS) was set as the primary endpoint. From July 2019 to October 2022, 106 eligible pts in total were enrolled. According to the treatment received, 72 and 34 pts were respectively allocated into FP cohort and TB cohort.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded).
  • Have progressed from at least 2 lines of standard treatment,including fluoropyrimidines, irinotecan, oxaliplatin, with or without targeted drugs, like bevacizumab and cetuximab (only for RAS wild-type). Regorafenib was permitted but not required for inclusion.
  • Has measurable or non-measurable disease as defined by RECIST version 1.1
  • Is able to swallow oral tablets.
  • Estimated life expectancy ≥12 weeks.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) less than 2
  • Has adequate organ function.

Exclusion criteria

  • Pregnancy, lactating female or possibility of becoming pregnant during the study.
  • Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy (excluding alopecia, and skin pigmentation).
  • Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
  • Has severe or uncontrolled active acute or chronic infection.
  • Known carriers of HIV antibodies.
  • Confirmed uncontrolled arterial hypertension or uncontrolled or symptomatic arrhythmia.

Treatment and study plan

FRUQUINTINIB

Drug

5mg once daily for 14 days on/7 days off, over a 21-day cycle

PD-1 Inhibitors

Drug

The anti-PD-1 antibody was administered intravenously on day 1, and its recommended dosage was as follows: nivolumab: 240 mg, every 2 weeks; pembrolizumab, camrelizumab, and sintilimab: 200 mg every 3 weeks; and toripalimab: 240 mg every 3 weeks.

Other names: anti-PD-1 antibodies

Trifluridine/tipiracil

Drug

TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days

Other names: TAS-102, Lonsurf, S 95005

Bevacizumab

Drug

Bevacizumab 5 mg /kg, intravenously on days 1,15,every 28 days

Other names: Avastin

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Approximately 12 months

    Overall survival defined as the observed time elapsed between the date of commencement of treatment and the date of death due to any cause

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: Approximately 12 months

    Progression-free survival defined as the time elapsed between the date of commencement of treatment and the date of radiologic tumour progression according to RECIST version 1.1 by investigator's judgement or death from any cause, whichever comes first.

  2. Overall response rate (ORR)

    Time frame: Approximately 12 months

    Overall response rate (ORR) was regarded as the proportion of complete responses (CRs) and partial responses (PRs) according to RECIST version 1.1 criteria and using investigator's tumor assessment

  3. Disease control rate (DCR)

    Time frame: Approximately 12 months

    Disease control rate has been defined as the addition of (CR + PR) rate and also stable disease (SD) rate

  4. Treatment-Related Adverse Events (TRAE)

    Time frame: Approximately 12 months

    Treatment-Related Adverse Events (TRAE) as assessed by CTCAE v5.0, including serious adverse events (SAEs)

Sponsors and collaborators

Lead sponsor

Hunan Cancer Hospital

Other

Registry information

Official study title

Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC: A Retrospective Cohort Study Based on Propensity Score Matching

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Sep 11, 2023
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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