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

NCT ID: NCT06031376

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 106 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2023-03-31

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.

Conditions

Metastatic Colorectal Adenocarcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Fruquintinib plus PD-1 inhibitors

In fruquintinib plus PD-1 inhibitors group,The patients were treated orally with Fruquintinib (5mg once daily for 14 days on/7 days off, over a 21-day cycle), combined with 1 of the 5 anti-PD-1 antibodies (i.e., nivolumab, pembrolizumab, camrelizumab, sintilimab, or toripalimab). 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.

Fruquintinib

Intervention Type: DRUG

5mg once daily for 14 days on/7 days off, over a 21-day cycle

PD-1 inhibitors

Intervention Type: DRUG

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.

TAS-102 plus bevacizumab

In TAS-102 plus BEV group, Patients received TAS-102 (35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days) and bevacizumab (5 mg /kg, intravenously, on days 1 and 15, every 28 days). Bevacizumab was approved to be a 30-minute intravenous infusion before TAS-102.

Trifluridine/Tipiracil

Intervention Type: DRUG

TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days

Bevacizumab

Intervention Type: DRUG

Bevacizumab 5 mg /kg, intravenously on days 1,15,every 28 days

Interventions

Fruquintinib

5mg once daily for 14 days on/7 days off, over a 21-day cycle

Intervention Type: DRUG

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.

Intervention Type: DRUG

Trifluridine/Tipiracil

TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days

Intervention Type: DRUG

Bevacizumab

Bevacizumab 5 mg /kg, intravenously on days 1,15,every 28 days

Intervention Type: DRUG

Other Intervention Names

anti-PD-1 antibodies; TAS-102; Lonsurf; S 95005; Avastin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rongrong li, professor

Role: PRINCIPAL_INVESTIGATOR

Hunan Cancer Hospital

Locations

Hunan Cancer hospital

Changsha, Hunan, China

Countries

China

Other Identifiers

FPTB-01

Identifier Type: -

Identifier Source: org_study_id