Clinical trial NCT06011330: Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer
Official title: Efficacy , Safety, and Predictors of Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer in a Real-world Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Fruquintinib
PD-1
pMMR/MSS
Lead sponsor: Hunan Cancer Hospital
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 70
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: Refractory MSS Metastatic Colorectal Cancer

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. 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;
2. Eligible patients were aged 18 years or older
3. had histologically or cytologically confirmed adenocarcinoma of the colon or rectum;
4. patients who have at least one non-resectable measurable lesion to evaluate by response evaluation criteria in solid tumors (RECIST version 1.1).
5. an Eastern Cooperative Oncology Group performance status of 0-2;

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: assessed up to 2 year
Secondary outcomes:
measure: progress-free survival (PFS)
timeFrame: assessed up to 1 year
Other outcomes:
measure: objective response rate (ORR)
timeFrame: assessed up to 1 year
measure: disease control rate (DCR)
timeFrame: assessed up to 1 year
measure: Treatment-Related Adverse Events (TRAE)
timeFrame: assessed up to 1 year
Locations:
city: ChangSha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
References: