Clinical trial NCT06031376: Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC
Official title: Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC: A Retrospective Cohort Study Based on Propensity Score Matching
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Adenocarcinoma
Keywords: Colorectal cancer; Fruquintinib;PD-1;TAS-102; bevacizumab
Lead sponsor: Hunan Cancer Hospital
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population were the patients treated with at least 2 cycle of fruquintinib plus PD-1 Inhibitors or TAS-102 plus BEV in patients suffering refractory mCRC from July 2019 to October 2022 at the Hunan Cancer Hospital.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded).
2. 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.
3. Has measurable or non-measurable disease as defined by RECIST version 1.1
4. Is able to swallow oral tablets.
5. Estimated life expectancy ≥12 weeks.
6. Eastern Cooperative Oncology Group performance status (ECOG PS) less than 2
7. Has adequate organ function.

Exclusion Criteria:

1. Pregnancy, lactating female or possibility of becoming pregnant during the study.
2. Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy (excluding alopecia, and skin pigmentation).
3. Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
4. 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Approximately 12 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Approximately 12 months
measure: Overall response rate (ORR)
timeFrame: Approximately 12 months
measure: Disease control rate (DCR)
timeFrame: Approximately 12 months
measure: Treatment-Related Adverse Events (TRAE)
timeFrame: Approximately 12 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer hospital
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Rongrong li, professor
role: PRINCIPAL_INVESTIGATOR
References: