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Completed

NCT Number: NCT06011330

Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer

The survival of the refractory CRC is dismal and therapy options are limited ,the researchers aim to investigate the efficacy, safety, and predictors of fruquintinib plus PD-1 in refractory MSS metastatic colorectal cancer in a real-world setting.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hunan Cancer Hospital

Changsha, Hunan, China

About this study

The invesgators conducted a retrospective single arm, single-center study in which patients with MSS/pMMR mCRC were received fruquintinib combined with anti-PD-1 antibodies after progressed at least two lines of standard chemotherapy with or without targeted drugs such as bevacizumab and cetuximab at the Hunan Cancer Hospital from 1th January 2019 to 30th June 2022. Eligible patients were aged 18 years or older and had histologically or cytologically confirmed adenocarcinoma of the colon or rectum; with patients who have at least one non-resectable measurable lesion to evaluate by response evaluation criteria in solid tumors (RECIST version 1.1).The primary endpoint was overall survival (OS).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with MSS/pMMR mCRC who have been received Fruquintinib combined with anti-PD-1 antibodies after progressed at least two lines of standard chemotherapy with or without targeted drugs such as bevacizumab and cetuximab at the Hunan Cancer Hospital from 1th January 2019 to 30th June 2022;
  • Eligible patients were aged 18 years or older
  • had histologically or cytologically confirmed adenocarcinoma of the colon or rectum;
  • patients who have at least one non-resectable measurable lesion to evaluate by response evaluation criteria in solid tumors (RECIST version 1.1).
  • an Eastern Cooperative Oncology Group performance status of 0-2;

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. 5.Known carriers of HIV antibodies. 6.Confirmed uncontrolled arterial hypertension or uncontrolled or symptomatic arrhythmia.

Treatment and study plan

Fruquintinib combined with anti-PD-1 antibodies

Drug

Fruquintinib (3-5mg once daily for 21 days on/7 days off) anti-PD-1 antibodies (including sintilimab, toripalimab, pembrolizumab, tislelizumab, and nivolumab).

Other names: programmed cell death protein 1, immune checkpoint inhibitor

Primary outcomes

  1. overall survival (OS)

    Time frame: assessed up to 2 year

    Overall survival defined as the observed time from the treatment of the study until death due to any cause

Secondary outcomes

  1. progress-free survival (PFS)

    Time frame: assessed up to 1 year

    the time from treatment initiation to the disease progression according to RECIST version 1.1 by investigator's judgement or death from any cause, whichever comes first.

Other outcomes

  1. objective response rate (ORR)

    Time frame: assessed up to 1 year

    The ORR was calculated as the sum of the proportion of complete responses (CRs) and partial responses (PRs) according to RECIST version 1.1 criteria and using investigator's tumor assessment

  2. disease control rate (DCR)

    Time frame: assessed up to 1 year

    Disease control rate has been defined as the addition of (CR + PR) rate and also stable disease (SD) rate, according to RECIST v 1.1

  3. Treatment-Related Adverse Events (TRAE)

    Time frame: assessed up to 1 year

    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

Efficacy , Safety, and Predictors of Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer in a Real-world Setting

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Aug 25, 2023
Registry last updated
Aug 30, 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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