Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06011330
• Other study ID #: FRUPD-1
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: February 10, 2023

Study information

• Verified date: August 2023
• Source: Hunan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 10, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	ChangSha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	objective response rate (ORR)	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	assessed up to 1 year
Other	disease control rate (DCR)	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	assessed up to 1 year
Other	Treatment-Related Adverse Events (TRAE)	Treatment-Related Adverse Events (TRAE) as assessed by CTCAE v5.0, including serious adverse events (SAEs)	assessed up to 1 year
Primary	overall survival (OS)	Overall survival defined as the observed time from the treatment of the study until death due to any cause	assessed up to 2 year
Secondary	progress-free survival (PFS)	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.	assessed up to 1 year