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Somatostatin

Lutetium Lu 177 dotatate

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Radiopharmaceuticals

Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) Lutetium\[177Lu\] Oxodotreotide Injection: Four administrations of 7.4 GBq (200 mCi).

Concomitant amino acids were given with each administration for kidney protection.

Lutetium\[177Lu\] Oxodotreotide Injection was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity.

In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.

Lutetium\[177Lu\] Oxodotreotide InjectionFour administrations of 7.4 GBq (200 mCi) Lutetium\[177Lu\] Oxodotreotide Injection administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity

Lutetium[177Lu] Oxodotreotide Injection

Ming Lu, professor

Zhi Yang, professor

his was a single-center, single-arm phase II study evaluate the efficacy and safety of Lutetium\[177Lu\] Oxodotreotide Injection in the first-line treatment of unresectable or metastatic, progressive, G2 or G3, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours.

After the screening period, participants who signed the ICF and were eligible for the study in accordance with the entry criteria were assigned to treatment with Lutetium\[177Lu\] Oxodotreotide Injection. Objective tumor assessment in both groups was performed every 12+/-1 weeks from the first treatment date according to RECIST 1.1 Criteria until progression.

Phase II Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate in the First-line Treatment of Patients With Locally Advanced or Metastatic, Somatostatin Receptor-positive G2 or G3 Gastroenteropancreatic Neuroendocrine Tumors

Phase II Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate in the First-line Treatment of Inoperable Patients With Locally Advanced or Metastatic, Somatostatin Receptor-positive G2 or G3 Gastroenteropancreatic Neuroendocrine Tumors

ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. For this analysis, ORR will be assessed in all participants

An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced ≥1 AE will be presented.

PFS is defined as the time from the date of first dose to the first documented disease

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase II Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate in the First-line Treatment of Patients With Locally Advanced or Metastatic, Somatostatin Receptor-positive G2 or G3 Gastroenteropancreatic Neuroendocrine Tumors	NCT05894486	Neuroendocrine ...	Lutetium[177Lu]...	18 Years - 75 Years	Peking University
Phase II Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate in the First-line Treatment of Patients With Locally Advanced or Metastatic, Somatostatin Receptor-positive G2 or G3 Gastroenteropancreatic Neuroendocrine Tumors	NCT05894486	Neuroendocrine ...	Lutetium[177Lu]...	18 Years - 75 Years	Peking University

Spots Global Cancer Trial Database for lutetium[177lu]