A Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy

A Single Center, Open-labeled, Single Arm Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy

This is a single center, open-labeled, single arm phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for advanced metastatic colorectal cancer patients unsuitable for intravenous chemotherapy.

Study Overview

• Status: Recruiting
• Conditions: Unresectable Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: fruquintinib plus capecitabine

Detailed Description

Fruquintinib is an oral small molecule inhibitor of VEGFR1/2/3, this phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for advanced metastatic colorectal cancer patients of elderly or those unsuitable for intravenous chemotherapy.

• Study Type: Interventional
• Enrollment (Anticipated): 49
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhigang Bai; Phone Number: +86-010-63138712; Email: baizhigang@ccmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ≥18 years old at the time of signing the informed consent;
2. Histologically or cytologically confirmed unresectable metastatic colorectal cancer;
3. Haven't received systematic therapy after diagnosis of metastatic colorectal cancer;
4. Intolerable to standard treatment of oxaliplatin- or irinotecan-based intravenous combination therapy;
5. At least one measurable lesion(s);
6. ECOG PS 0-2;
7. Life expectancy≥3 months;
8. Adequate organ and bone marrow functions;
9. Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration;
10. Willingness and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria:

1. Previous treatment with VEGFR inhibition;
2. Participating in other drug clinical trials within 4 weeks before recruited;
3. Have received other systemic anti-tumor therapies within 4 weeks before recruited;
4. Non-controlled hypertension after monotherapy, that is, systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg;
5. Proteinuria ≥ 2+ (1.0g/24hr);
6. Clinically significant electrolyte abnormality;
7. Clinically significant cardiovascular diseases;
8. Thromboembolism or arteriovenous events occurred 6 months before recruited;
9. ≥grade 3 bleeding events 4 weeks before recruited;
10. Evidence of CNS metastasis;
11. Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI;
12. Active, symptomatic interstitial lung disease causing dyspnea (≥ grade 2 dyspnea), pleural effusion or ascites;
13. History of organ transplantation;
14. APTT >1.5×ULN or INR>1.5;
15. History of HIV infection or active hepatitis B / C;
16. Allergic to fruquintinib and / or capecitabine;
17. Pregnant or lactating women;
18. Clinically detectable secondary primary malignancies at the time of enrollment (excluding fully treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);
19. Patients who are not suitable for the study judged by the researchers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Fruquintinib, 4mg/d, qd po, 2 weeks on, 1 week off; Capecitabine: 825mg/m2, bid po, 2 weeks on, 1 week off	Drug: fruquintinib plus capecitabine; oral fruquintinib plus capecitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1	From Baseline to primary completion date, about 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is determined from the date of treatment to death from any cause or the last follow-up date	From Baseline to primary completion date, about 3 years
Progression Free Survival (PFS)	PFS is determined from the date of treatment to PD or death from any cause	From Baseline to primary completion date, about 3 years
Disease Control Rate (DCR)	DCR according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1	From Baseline to primary completion date, about 3 years
Adverse Events and Serious Adverse Events	Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0.	From Baseline to primary completion date, about 3 years
Quality of Life (QoL)	Quality of life is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30. It will be evaluated at Screening, Tumor Assessment Visit and End of Treatment visit.	From Baseline to primary completion date, about 3 years

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2021
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: HMPL-013-FLAG-C104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No