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

NCT06031376 | Completed

• 1 other identifier: FPTB-01
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Adenocarcinoma

Keywords

Colorectal cancer; Fruquintinib;PD-1;TAS-102; bevacizumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Progression-free survival (PFS)

  Approximately 12 months

• Overall response rate (ORR)

  Approximately 12 months

• Disease control rate (DCR)

  Approximately 12 months

• Treatment-Related Adverse Events (TRAE)

  Approximately 12 months

Study Arms (2)

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.

Drug: Fruquintinib; Drug: PD-1 inhibitors

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.

Drug: Trifluridine/Tipiracil; Drug: Bevacizumab

Interventions

Fruquintinib DRUG

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

Fruquintinib plus PD-1 inhibitors

PD-1 inhibitors 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.

Also known as: anti-PD-1 antibodies

Fruquintinib plus PD-1 inhibitors

Trifluridine/Tipiracil DRUG

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

Also known as: TAS-102, Lonsurf, S 95005

TAS-102 plus bevacizumab

Bevacizumab DRUG

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

Also known as: Avastin

TAS-102 plus bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Pregnancy, lactating female or possibility of becoming pregnant during the study.
• Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy (excluding alopecia, and skin pigmentation).
• Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
• Has severe or uncontrolled active acute or chronic infection.
• Known carriers of HIV antibodies.
• Confirmed uncontrolled arterial hypertension or uncontrolled or symptomatic arrhythmia.

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

Study Sites (1)

Hunan Cancer hospital

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

HMPL-013; Immune Checkpoint Inhibitors; trifluridine tipiracil drug combination; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Rongrong li, professor

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2023
• First Posted: September 11, 2023
• Study Start: July 1, 2019
• Primary Completion: October 31, 2022
• Study Completion: March 31, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: please contact the principal investigator of this study or correspondence author.

Locations

CN (1)