NCT07483684 Tipiracil Hydrochloride/Trifluridine Advanced Colorectal Adenocarcinoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07483684 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: 17 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07483684 is a hot trial to watch
Advanced Colorectal Adenocarcinoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07483684 is notable because it evaluates Tipiracil Hydrochloride/Trifluridine in a Phase 3 design sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. 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 | NCT07483684 |
| Official title | A Clinical Study to Evaluate Injection TQB2102 for the Treatment of Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxaliplatin, Irinotecan and Fluoropyrimidine-Based Drugs |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | Tipiracil Hydrochloride/Trifluridine |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Geography | China |
| Enrollment | [object Object] |
| Primary endpoint | Progression-Free Survival (PFS) assessed by IRC based on RECIST v1.1 |
| Endpoint time frame | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This is a Phase III, randomized, open-label, active-controlled, multicenter study designed to evaluate the efficacy and safety of Injection TQB2102 compared with investigator's choice of treatment in subjects with Human Epidermal Growth Factor Receptor 2 (HER2) ImmunoHistoChemistry score 3 (IHC3+) advanced colorectal cancer who have failed prior treatment with oxaliplatin, irinotecan, and fluoropyrimidine-based regimens. The primary endpoint of this study is progression-free survival (PFS) as assessed by an Independent Review Committee (IRC). The key secondary endpoint is overall survival (OS). Other secondary endpoints include investigator-assessed PFS, objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR), safety, and quality of life scores. Approximately 142 subjects are planned to be enrolled. Eligible subjects will be randomly assigned in a 1:1 ratio to the experimental group
Allocation is Randomized, masking is None (Open Label), 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.
- Progression-Free Survival (PFS) assessed by IRC based on RECIST v1.1 (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months) — To evaluate the Progression-Free Survival (PFS) assessed by IRC of TQB2102 Injection compared to investigator-selected chemotherapy in subjects.
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: Tipiracil Hydrochloride/Trifluridine is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is resolved to a normalized organization record in Lianyungang, 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
NCT07483684 provides a focused lens on Advanced Colorectal Adenocarcinoma development. Its value will be determined by whether Tipiracil Hydrochloride/Trifluridine can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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