ChiCTR2600125446 KAL-002 Radiation enteritis of intestine Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines ChiCTR2600125446 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: 23 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why ChiCTR2600125446 is a hot trial to watch
Radiation enteritis of intestine is being segmented by mechanism, treatment setting, geography and endpoint architecture. ChiCTR2600125446 is notable because it evaluates KAL-002 in a Phase 2 design sponsored by Qilu Hospital of Shandong 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 | ChiCTR2600125446 |
| Official title | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Trial Evaluating the Safety and Efficacy of KAL-002 for Preventing Radiation Enteritis |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | KAL-002 |
| Sponsor | Qilu Hospital of Shandong University |
| Geography | China |
| Enrollment | [object Object] |
| Primary endpoint | The incidence of grade 2–4 radiation enteritis related diarrhea during the study period |
| Endpoint time frame | At Day 15, Day 29, and Day 49 post-treatment |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The indexed record describes a Phase 2 study of KAL-002 in Radiation enteritis of intestine.
Allocation is not reported, 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.
- The incidence of grade 2–4 radiation enteritis related diarrhea during the study period (At Day 15, Day 29, and Day 49 post-treatment) — During the trial period, participants recorded daily bowel movement frequency and Bristol stool score in a diary card. The incidence of grade 2–4 diarrhea during the study was assessed by the investigator according to CTCAE v5.0 grading criteria for diarrhea.
- Safety outcomes (At Day 15, Day 29, and Day 49 post-treatment) — The safety of KAL-002 versus placebo will be evaluated based on AE, SAE, clinical laboratory tests, vital signs, physical examination, 12-lead electrocardiogram and other examinations.
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: KAL-002 is indexed as Microbiota, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status Phase 2.
Company & Deal Intelligence MCP profile: Qilu Hospital of Shandong University did not return an exact normalized organization match in this snapshot. 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
ChiCTR2600125446 provides a focused lens on Radiation enteritis of intestine development. Its value will be determined by whether KAL-002 can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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