ChiCTR2600127254 Dexamethasone Sodium Phosphate Nausea Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready landscape. This focused report examines ChiCTR2600127254—A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of Rolapitant Palonosetron for Injection in Preventing Nausea and Vomiting Induced by Antibody-Drug Conjugates, Using Fosaprepitant Dimeglumine for Injection Combined with Palonosetron Hydrochloride as the Active Control—using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, Drug & Asset MCP for mechanism and development context, and Company & Deal Intelligence MCP for sponsor background. Explore PatSnap MCP Servers to reproduce the workflow inside an AI research process.
MCP evidence snapshot: 20 July 2026; publication date: 20 July 2026. Trial records can change after the snapshot and should be rechecked before operational decisions.
Why ChiCTR2600127254 is a hot trial to watch
Nausea is increasingly segmented by mechanism, biomarker, treatment setting, geography and endpoint architecture. ChiCTR2600127254 is notable because it evaluates Dexamethasone Sodium Phosphate in a Phase 2 design while Proportion of participants achieving complete response on Days 1–14 of ADC treatment serves as the main decision variable. The critical question is whether the protocol can convert its rationale into a clinically interpretable and operationally credible readout.
PatSnap Clinical Trials MCP makes protocol fields machine-readable, while the companion asset and organization servers add development-status, target and sponsor context.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | ChiCTR2600127254 |
| Official title | A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of Rolapitant Palonosetron for Injection in Preventing Nausea and Vomiting Induced by Antibody-Drug Conjugates, Using Fosaprepitant Dimeglumine for Injection Combined with Palonosetron Hydrochloride as the Active Control |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Dexamethasone Sodium Phosphate, Palonosetron hydrochloride, Fosrolapitant/Palonosetron, HR20013 injection analog, fosaprepitant dimeglumine injection, palonosetron hydrochloride injection, dexamethasone acetate tablets, and dexamethasone acetate tablet analog., HR20013 for injection, fosaprepitant dimeglumine injection simulant, palonosetron hydrochloride injection simulant, and dexamethasone acetate tablets., 注射用 HR20013 模拟剂、注射用福沙匹坦双葡甲胺、盐酸帕洛诺司琼注射液、醋酸地塞米松片和醋酸地塞米松片模拟剂。, 注射用 HR20013、注射用福沙匹坦双葡甲胺模拟剂、盐酸帕洛诺司琼注射液模拟剂和醋酸地塞米松片。 |
| Sponsor | Beijing Tumor Hospital, Beijing Institute for Cancer Research |
| Collaborators | Not reported |
| Geography | China |
| Enrollment | 62 |
| Primary endpoint | Proportion of participants achieving complete response on Days 1–14 of ADC treatment |
| Endpoint time frame | Not reported |
| Primary completion / readout proxy | [object Object] |
Design and endpoint interpretation
The phase label is only the starting point. Allocation is Not reported, masking is Not reported, and the intervention model is Parallel Assignment. Planned enrollment of 62 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.
- Primary: Proportion of participants achieving complete response on Days 1–14 of ADC treatment
- Secondary: Proportion of trial participants who achieved complete remission throughout the ADC treatment cycle
- Secondary: Proportion of trial participants with no significant nausea during days 1-14 of ADC treatment
- Secondary: Proportion of trial participants with no nausea during ADC treatment from day 1 to 14
- Secondary: Proportion of trial participants with no vomiting episodes from days 1 to 14 of ADC treatment
Benchmark readouts in the surrounding field
- Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer (Phase 3): Cycle 1(Mean) = 4.51 units on a scale (Standard Error, 0.155); Cycle 1(Mean) = 4.93 units on a scale (Standard Error, 0.141)
- Phase III Randomized Control Trial Investigating Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients With Gynecologic Malignancies Receiving Every 3-week Carboplatin and Paclitaxel Chemotherapy (Phase 3): Rate of Complete Response in the Overall Time Period (0 - 120 Hours Post-chemotherapy) = 11 Participants ; Rate of Complete Response in the Overall Time Period (0 - 120 Hours Post-chemotherapy) = 14 Participants
- Effects of Aromatherapy on Chemotherapy-Induced Nausea and Vomiting: A Control Trial (Phase 2): Acute Nausea (24 hours after chemotherapy begins) - MAT Question # 4(Mean) = 4.57 score on a scale (Standard Deviation, 0.34); Acute Nausea (24 hours after chemotherapy begins) - MAT Question # 4(Mean) = 5.35 score on a scale (Standard Deviation, 0.30)
These indexed results are contextual benchmarks, not direct head-to-head evidence. Population, treatment line, endpoint definitions, follow-up and analysis sets may differ. Their value is to clarify the type and magnitude of evidence already visible in the competitive landscape.
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Asset and sponsor context
Drug & Asset context: Dexamethasone Sodium Phosphate (Approved; GR); Palonosetron hydrochloride (Approved; HTR3); Fosrolapitant/Palonosetron (Approved; HTR3A x NK1R)
Company & Deal Intelligence context: Beijing Tumor Hospital — China — http://www.bjcancer.org/_english/service.html; Beijing Institute for Cancer Research — China — http://www.bjcancer.org
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 decide 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.
- Sequencing evidence: comparative data after the most 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 probability of success before a headline data release.
Bottom line
ChiCTR2600127254 is a focused lens on Nausea development. Its value will be determined by whether Dexamethasone Sodium Phosphate can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from indexed benchmark readouts.
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