Current partner codePEPTIDESDE
NCT05884255·Phase 3·INTERVENTIONAL

An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.

Status

Recruiting

Phase

Phase 3

Enrollment

220

Locations

2

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.

Interventions

Treatment arms and agents.

DRUG

Lutetium (177Lu) Oxodotreotide Injection;long-acting Octreotide

Lutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide.

DRUG

long-acting Octreotide

High-dose long-acting Octreotide.

Timeline

From registration to results.

  1. First posted

    Jun 1, 2023

  2. Study start

    Jul 6, 2023

  3. Primary completion

    Dec 2026

  4. Study completion

    Oct 2030

  5. Results posted

    Not reported

  6. Registry updated

    May 19, 2026

Outcomes

What the study measures.

Primary outcomes

Progression-free survival (PFS) assessed by BICR

Time frame · Up to 1 year follow-up

Secondary outcomes

Overall Survival (OS)

Time frame · Up to 5 years follow-up

Objective Response Rate (ORR)

Time frame · up to 1 year follow-up

Duration of Overall Response (DoR)

Time frame · Up to 1 year follow-up

Disease Control Rate (DCR)

Time frame · Up to 1 year follow-up

Incidence and severity of adverse event (AE) and serious adverse event (SAE)

Time frame · Up to 5 years follow-up

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: 1. Able and willing to provide a written informed consent; 2. 18\~75 years old,male or female; 3. ECOG performance status 0 or 1; 4. Unresectable locally advanced or metastatic gastrointestinal neuroendocrine tumors (GEP-NETs) of low and medium grade (G1 or G2) confirmed by histopathology. Exclusion Criteria: 1. Central nervous system metastasis is known. Patients who have previously received treatment ( radiotherapy or surgery ) for brain metastases and have no clinical symptoms can be enrolled if the pre-randomized pre-imaging is confirmed to be stable for at least 24 weeks; 2. There are clinical symptoms or diseases of the heart that are not well controlled; 3. Diabetes (fasting blood glucose \> 2 × ULN) that cannot be well controlled after optimal medical support treatment; 4. Severe urinary incontinence, hydronephrosis, severe micturition dysfunction or indwelling catheter for any reason.

Study locations

2 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Tianjin University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Octreotide.

Related PeptideStat pages

Put the record in context.

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