Fruquintinib in the Cross-line Treatment of Refractory mCRC

Metastatic Colorectal Cancer Clinical Trial

Official title:

A Real-world Study of Fruquintinib in the Cross-line Treatment of Refractory mCRC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06099314
• Other study ID #: HMPL-013-C2-CRC05
• Status: Recruiting
• Start date: October 2023
• Est. completion date: September 2025

Study information

• Verified date: October 2023
• Source: Wuhan Union Hospital, China
• Contact: Zhenyu Lin
• Phone: 15827130393
• Email: whxhlzy[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a real-world study. Patients with metastatic colorectal cancer who have progressed (PD) after third-line treatment with fruquintinib combined with PD-1 inhibitors will receive fruquintinib combined with TAS-102 as fourth-line therapy. The objective of this study was to observe the efficacy and safety of cross-line（from third to fourth line）treatment with fruquinitinib.

Description:

This is a real-world study. Patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-VEGF, anti-EGFR (RAS and BRAF wild type) (treatment with anti-VEGF-TKI is not allowed), and had received fruquinitinib combined with PD-1 inhibitors for third-line treatment. After progression (PD) (confirmed by RECIST 1.1 ), fruquinitinib combined with TAS-102 as fourth-line therapy was received. The primary endpoint was observation the overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102. The study objective is to explore the possibility of cross-line rechallenge of fruquinitinib.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

-

To be enrolled in this study, patients must meet all of the following criteria:

1. Age =18 years, =75 years;

2. No gender limitation;

3. Patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-VEGF, anti-EGFR (RAS and BRAF wild type) (treatment with anti-VEGF-TKI is not allowed), and had received fruquinitinib combined with PD-1 inhibitors for third-line treatment. After progression (PD) (confirmed by RECIST 1.1 ), fruquinitinib combined with TAS-102 as fourth-line therapy was received.

4. Expected survival =12 weeks

5. Must have at least one measurable lesion (RECIST1.1).

6. Full organ and bone marrow function.

Exclusion Criteria:

-

Patients will not be admitted to the study if they meet any of the following criteria:

1. Patients with contraindications to study drugs (fruquinitinib, PD-1 inhibitor, TAS-102);

2. allergic to the investigational drug or any of its adjuncts;

3. There are other non-investigational drugs during third-line and fourth-line treatment;

4. Pregnant or lactating female subjects;

5. Patients with a large number of pleural effusion or ascites requiring drainage;

6. Patients considered unsuitable for inclusion in this study by the investigators.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Fruquintinib+PD-1 inhibitors
Third-line treatment with fruquintinib combined with PD-1 inhibitors. Fruquintinib: 5mg,Oral once daily,2 weeks on/1 week off,Q3W; PD-1 inhibitor:for example, Sintilimab,iv,200mg, Q3W.
• Fruquintinib+TAS-102
Fourth-line treatment with fruquintinib combined with TAS-102 . Fruquintinib: 3-5mg(Depending on the patient's physical condition), Oral once daily,3 weeks on/1 week off,Q4W; TAS-102:orally, 35mg/m2 twice daily (maximum dose 80mg in a single dose) for days 1-5, repeated every 14 days.

Locations

Country	Name	City	State
China	TONGJI Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival 2(OS2)	Overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102	From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented date of death from any cause , assessed up to 12 months
Secondary	Objective response rate 2(ORR2, investigator based on RECIST1.1)	Objective response rate (ORR) of fourth-line treatment of mCRC with fruquinitinib and TAS-102	from received fruquinitinib combined with TAS-102 to one year
Secondary	Progression-free survival 2(PFS2, investigators based on RECIST1.1)	Progression-free survival (PFS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102	From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary	Disease control rate 2 (DCR2, investigators based on RECIST1.1)	Disease control rate (DCR) of fourth-line treatment of mCRC with fruquinitinib and TAS-102	from received fruquinitinib combined with TAS-102 to one year