A case-control study of Fruquintinib combined with anti-PD-1 versus PD-1 in the treatment of metastatic colon cancer (a randomized, open-label phase II clinical trial)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100051400

Enrollment

Unknown

Registered

2021-09-23

Start date

2021-12-01

Completion date

Unknown

Last updated

2022-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

Fruquintinib combined with anti-PD-1 group:Fruquintinib combined with Pembrolizumab

Anti-PD-1 group:Pembrolizumab

Eligibility

Sex/Gender

All

Age

20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Pathologically confirmed as colorectal cancer; 2.After radical resection of colorectal cancer; 3.Postoperative pathological staging stage II-III; 4.Confirmed as dMMR-MSI-H; 5.Distant metastasis occurred in postoperative review; 6.Aged 20 to 80 years; 7.ECOG score 0-1 points; 8.White blood cell count>4x10^9/L, platelet count>80x10^9/L, liver and kidney function normal, electrocardiogram normal, no immunotherapy contraindications.

Exclusion criteria

Exclusion criteria: 1.Previous anti-PD-1 or anti-PD-L1 treatment; 2.Previous anti-vascular treatment; 3.Patients who have participated in other clinical studies in the last 4 weeks; 4.The researcher believes that there are other circumstances that are not suitable for participating in this research.

Design outcomes

Primary

Measure	Time frame
The level of adverse reactions in patients;Patient quality of life score;	—

Secondary

Measure	Time frame
1-year and 3-year overall survival;1-year and 3-year progression-free survival rates;	—

Countries

China

Contacts

Public ContactFu Weihua

Tianjin Medical University General Hospital

tjmughgs_fwh@163.com+86 13821661125

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026