NCT07562659 Capecitabine Colorectal Cancer Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07562659 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 24 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07562659 is a hot trial to watch
Colorectal Cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07562659 is notable because it evaluates Capecitabine in a Phase 2 design sponsored by Fudan University. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07562659 |
| Official title | Randomized Controlled Study of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy in Stage I/Low-Risk Stage II Colorectal Cancer (CLEAR-01) |
| Phase / status | Phase 2 / Recruiting |
| Intervention | Capecitabine |
| Sponsor | Fudan University |
| Geography | China |
| Enrollment | [object Object] |
| Primary endpoint | Patient's 2-year Progression-Free Survival |
| Endpoint time frame | Two-year Progression-Free Survival |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This study will utilize ctDNA methylation detection to evaluate patients with stage I or low-risk stage II colorectal cancer who are ctDNA-positive one month after surgery. It aims to investigate the impact of different adjuvant chemotherapy regimens on ctDNA clearance rates and their prognostic significance. By using postoperative ctDNA status to identify patients at high risk of recurrence, the study seeks to implement intensified chemotherapy strategies (treatment escalation) at an early stage, thereby improving ctDNA clearance and ultimately enhancing patient outcomes.
Allocation is Randomized, masking is Double, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across China shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Patient's 2-year Progression-Free Survival (Two-year Progression-Free Survival) — Two-year Progression-Free Survival (PFS) is defined as the proportion of patients who remain alive without evidence of disease progression or recurrence within 24 months from the date of surgery (or randomization, as specified in the protocol). Disease progression is determined according to radiologic, clinical, or pathological criteria.
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Capecitabine is indexed as Small molecule drug, with target TYMS, mechanism TYMS inhibitors, and global highest development status Approved.
Company & Deal Intelligence MCP profile: Fudan University is resolved to a normalized organization record in Shanghai Shi, China. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07562659 provides a focused lens on Colorectal Cancer development. Its value will be determined by whether Capecitabine can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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