# A Multicenter, Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Concurrent Combination Therapy of S-531011 Plus Fruquintinib or S-531011 Plus F

Source: https://onco.cc/trials/nct07591597/  
OnCo record `nct07591597` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of fruquintinib and pembrolizumab in colorectal cancer, run by National Cancer Center Hospital East, not yet recruiting.

## Summary

A Multicenter, Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Concurrent Combination Therapy of S-531011 Plus Fruquintinib or S-531011 Plus Fruquintinib Plus Pembrolizumab in Patients With MSS/pMMR Colorectal Cancer is a phase 1/2, interventional study registered as NCT07591597 by National Cancer Center Hospital East, with a registry enrolment figure of 68 participants, started 2026-05 and due to reach its primary completion in 2027-07. Interventions recorded: S-531011; Fruquintinib; Pembrolizumab. Conditions listed: Metastatic Colorectal Neoplasms; Microsatellite Stable / Proficient Mismatch Repair Colorectal Cancer. Primary outcome: Dose-Limiting Toxicity (DLT) Rate [Phase Ib Part]; Objective Response Rate (ORR) [Phase II Part]. Colorectal eligibility wording from the registry: "Patients with histologically confirmed unresectable adenocarcinoma of the colon or rectum". No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: planned
- Last checked: 2026-09-24
- Also known as: IGNITE-CRC
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: NCT07591597
- Phase: 1/2
- Setting: A Multicenter, Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Concurrent Combination Therapy of S-531011 Plus Fruquintinib or S-531011 Plus Fruquintinib Plus Pembrolizumab in Patients With MSS/pMMR Colorectal Cancer
- Sponsor: National Cancer Center Hospital East
- Enrolled: 68

## Sources

- ClinicalTrials.gov NCT07591597: https://clinicaltrials.gov/study/NCT07591597

## Connected records

- cancers: [Colon cancer (adenocarcinoma of the colon)](https://onco.cc/cancers/colon-cancer/), [Mismatch-repair deficient (MSI-high) colorectal cancer](https://onco.cc/cancers/msi-high-colorectal/), [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [Anti-angiogenic therapy](https://onco.cc/technologies/antiangiogenic/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Fruquintinib](https://onco.cc/drugs/fruquintinib/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Shionogi](https://onco.cc/companies/shionogi/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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