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 | Not Yet Recruiting Phase 2

• 1 other identifier: XT-XTR008-2-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuroendocrine Tumors

Keywords

PRRT; Lutetium[177Lu]

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in all participants

  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

  Up to 2 years

Secondary Outcomes (3)

• Incidence of Treatment-Related Adverse Events

  Until 30 days after the last treatment

• Progression-free Survival (PFS) per RECIST 1.1 in all participants

  Up to 2 years

• Disease control rate(DCR)

  Up to 2 years

Study Arms (1)

Lutetium[177Lu] Oxodotreotide Injection

EXPERIMENTAL

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.

Drug: Lutetium[177Lu] Oxodotreotide Injection

Interventions

Lutetium[177Lu] Oxodotreotide Injection DRUG

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

Also known as: 177Lu-DOTA0-Tyr3-Octreotate

Lutetium[177Lu] Oxodotreotide Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and willingness to sign a written informed consent document.
• Aged 18-75 years.
• Histopathologically confirmed G2 or G3 unresectable locally advanced or metastatic GEP-NET, Ki67 index ≥10 and ≤ 55%. (based on the fifth edition of the WHO classification and grading criteria for neuroendocrine， tumors of the digestive system in 2019, to be centrally confirmed).
• Subjects have not received prior systemic antitumor therapy for the current stage of NET.
• Presence of at least 1 measurable site of disease (based on RECIST 1.1).
• All target lesions (based on RECIST 1.1) at baseline must be confirmed as growth inhibitor receptor positive by 68Ga-Dotatate PET/CT.
• ECOG score of 0 or 1.
• Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, IUDs, etc., during treatment and within 3 months of the last use of the trial drug.

You may not qualify if:

• Serum creatinine \>150 μmol/L (1.7 mg/dL) or creatinine clearance \<50 ml/min (Cockcroft Gault formula).
• Hemoglobin \<80g/L, or white blood cell count \<2.0×109/L, or platelets \<75×109/L.
• Serum total bilirubin \> 3 × upper limit of normal (ULN).
• Serum albumin \<30g/L.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5×ULN.
• International normalized ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \> 1.5 x ULN.
• Pregnant or lactating females.
• Received peptide receptor radionuclide therapy(PRRT) prior to randomization.
• Received the following treatments within 4 weeks prior to treatment, including but not limited to surgery (except biopsy), radical radiotherapy, hepatic artery interventional embolization, cryoablation of liver metastases, or radiofrequency ablation.
• Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to randomization.
• Toxicity of prior antitumor therapy has not returned to ≤ grade 1 levels (except for alopecia).
• Received external beam radiation therapy for bone metastases within 2 weeks prior to treatment.
• More than 25% of bone marrow with prior external radiation radiotherapy.
• Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrollment in the study.
• Uncontrolled congestive heart failure.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

lutetium Lu 177 dotatate

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Central Study Contacts

Ming Lu, professor

CONTACT

86-10-88196561; qiminglu_mail@126.com

Zhi Yang, professor

CONTACT

13701382886; pekyz@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: June 5, 2023
• Primary Completion: June 5, 2025
• Study Completion (Estimated): June 5, 2026
• Last Updated: June 8, 2023

Record last verified: 2023-05

Locations

CN (1)