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

Metastatic Colorectal Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06031376
• Other study ID #: FPTB-01
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: March 31, 2023

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 31, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Colorectal Adenocarcinoma

Intervention

Drug:
• Fruquintinib
5mg once daily for 14 days on/7 days off, over a 21-day cycle
• PD-1 inhibitors
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.
• Trifluridine/Tipiracil
TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days
• Bevacizumab
Bevacizumab 5 mg /kg, intravenously on days 1,15,every 28 days

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
Primary	Overall Survival (OS)	Overall survival defined as the observed time elapsed between the date of commencement of treatment and the date of death due to any cause	Approximately 12 months
Secondary	Progression-free survival (PFS)	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.	Approximately 12 months
Secondary	Overall response rate (ORR)	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	Approximately 12 months
Secondary	Disease control rate (DCR)	Disease control rate has been defined as the addition of (CR + PR) rate and also stable disease (SD) rate	Approximately 12 months
Secondary	Treatment-Related Adverse Events (TRAE)	Treatment-Related Adverse Events (TRAE) as assessed by CTCAE v5.0, including serious adverse events (SAEs)	Approximately 12 months