Sinotau widens China trial of Lu-177 oxodotreotide as enrollment target rises to 85
The registry update lifts the target enrollment for Sinotau's Phase 2/3 study by 11 patients and reopens recruiting, tracking toward a 2027 primary completion in a China-only neuroendocrine tumor trial.
Executive Summary
- Sinotau Pharmaceutical Group increased the enrollment target for its Phase 2/3 study of Lutetium Oxodotreotide in advanced neuroendocrine neoplasms and shifted the trial's status back to Recruiting after a period of Active, not recruiting.
- The trial's amendment history reads as stable, with a single documented change per year and no delays to its stated primary completion date, suggesting the enrollment adjustment reflects routine trial management rather than a program in distress.
- The company operates in a field where several other sponsors are running SSTR2-targeted radiopharmaceuticals in Phase 3 testing, though none directly overlaps this trial's specific combination of geography, patient population, and design.
- The trial's two-part design separates a safety assessment from a later efficacy readout on objective response, meaning the informative signal from this program will not arrive until the response-rate analysis, not from this enrollment update.
The update
The trial, registered as NCT06398444, raised its anticipated enrollment target from 74 to 85 patients and moved back to a Recruiting status after previously showing as Active, not recruiting since September 2025. The study is testing Lutetium Oxodotreotide, a radiolabeled somatostatin receptor agonist, in patients with inoperable, locally advanced or metastatic neuroendocrine neoplasms who have exhausted or cannot access optimal available treatment. It is running exclusively in China, started in June 2024, and lists a primary completion date of June 1, 2027. NCT06398444A Clinical Study of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine NeoplasmsNCT06398444
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The design
The trial is structured in two parts: Part 1 evaluates the incidence and severity of adverse events through six months after the last dose, and Part 2 measures Overall Response Rate assessed by an independent review committee, tracked out to five years. Eligible patients must be at least 12 years old, have an ECOG performance status of 0 or 1, and confirm somatostatin receptor positivity on baseline imaging. The trial carries 18 secondary endpoints spanning progression-free survival, disease control rate, overall survival, and quality-of-life measures, reflecting a program designed to generate a broad efficacy and tolerability package rather than a narrow pivotal comparison. NCT06398444A Clinical Study of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine NeoplasmsNCT06398444
Trial stability
The enrollment increase from 74 to 85 patients sits within the range the operational model treats as routine for a trial at this stage, and the trial's registry-churn profile is labeled Stable, with roughly one documented change per year since it opened in 2024. The study's primary completion date has not moved since it was first registered, and no endpoint amendments have been recorded. The status reversion to Recruiting follows the pattern of a program resuming patient intake after an enrollment pause, not a signal of a trial in difficulty. NCT06398444A Clinical Study of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine NeoplasmsNCT06398444
The competitive field
SSTR2-targeted radiopharmaceuticals form an active but not novel category: Novartis is running a Phase 3 trial of Ga-DOTA-TATE in neuroendocrine neoplasms, and other sponsors, including RayzeBio with Actinium-225 Dotatate and Jiangsu HengRui Medicine with its own Lutetium (177Lu) Oxodotreotide, have Phase 3 programs targeting SSTR2 in related gastroenteropancreatic neuroendocrine tumor populations. None of these directly matches this trial's China-only enrollment, its inclusion of non-GEP-NET neuroendocrine neoplasms such as pheochromocytoma and paraganglioma, or its two-part safety-then-efficacy design, leaving Sinotau's program without a same-target, same-indication comparator that has advanced past Phase 2.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.