Liposomal Irinotecan Combination Regimen for Second-line Treatment of Advanced Gastric Cancer

NCT06486545 | Not Yet Recruiting

• 1 other identifier: nal-IRI-GC-01
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

Liposomal irinotecan, intravenous infusion 90min, d1: Grade 1:50mg/m2 Grade 2:60mg/m2 Grade 3:70mg/m2 Albumin-paclitaxel, 150mg/m2, intravenous infusion, d1 DLT was observed for 2 weeks (the first cycle). The same subject received only one dose of liposomal irinotecan during the study. All subjects underwent protocol-mandated examinations during treatment to observe safety and initial efficacy. If the patient volunteers and the investigator determines that the benefits of continuing the original regimen outweigh the risks, the subject may continue to receive treatment for metastatic disease. The drug was repeated every 2 weeks for up to 6 cycles, and the albumin paclitaxel or liposomal irinotecan were withdrawn according to the patient's adverse reactions and physical status, and the remaining single-agent maintenance therapy was performed. Until there is a possibility of surgery, disease progression, intolerable toxicity or the patient withdraws informed consent (whichever comes first).

Conditions

Advanced Gastric Cancer

Keywords

Gastric cancer and gastroesophageal junction adenocarcinoma; Liposomal irinotecan; Albumin-paclitaxel; Second-line treatment; Dose escalation

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  To estimate the maximum tolerated dose of liposomal irinotecan in the combination regimen based on dose-limiting toxicity

  From the recorded first dose of Liposomal irinotecan to 4 weeks after the recorded last dose of Liposomal irinotecan.

Secondary Outcomes (5)

• Dose-limiting Toxicity (DLT) of liposomal irinotecan

  From the recorded first dose of Liposomal irinotecan to 4 weeks after the recorded last dose of Liposomal irinotecan.

• Objective response rate

  Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.

• Disease control rate

  Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.

• Progression-free survival

  Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years.

• Overall survival

  The time from beginning of Liposomal irinotecan treatment until death due to any cause and will be assessed up to 3 years.

Study Arms (1)

Liposomal irinotecan + Albumin-paclitaxel

EXPERIMENTAL

Liposomal irinotecan, intravenous infusion 90min, d1: Grade 1:50mg/m2； Grade 2:60mg/m2； Grade 3:70mg/m2； Albumin-paclitaxel, 150mg/m2, intravenous infusion, d1

Drug: Irinotecan Hydrochloride Liposome Injection；Paclitaxel For Injection (Albumin Bound)

Interventions

Irinotecan Hydrochloride Liposome Injection；Paclitaxel For Injection (Albumin Bound) DRUG

Liposomal irinotecan, intravenous infusion 90min, d1: Grade 1:50mg/m2； Grade 2:60mg/m2； Grade 3:70mg/m2； Albumin-paclitaxel, 150mg/m2, intravenous infusion, d1 DLT was observed for 2 weeks (the first cycle). The same subject received only one dose of liposomal irinotecan during the study. If the patient volunteers and the investigator determines that the benefits of continuing the original regimen outweigh the risks, the subject may continue to receive treatment for metastatic disease. The drug was repeated every 2 weeks for up to 6 cycles, and the albumin paclitaxel or liposomal irinotecan were withdrawn according to the patient's adverse reactions and physical status, and the remaining single-agent maintenance therapy was performed. Until there is a possibility of surgery, disease progression, intolerable toxicity or the patient withdraws informed consent (whichever comes first).

Liposomal irinotecan + Albumin-paclitaxel

Eligibility Criteria

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

You may qualify if:

• Patients fully understand the study, voluntarily participate and sign an informed consent form (ICF)
• Age ≥18 years
• The expected survival time is ≥3 months
• Patients with histologically or pathologically confirmed unresectable or locally advanced gastric cancer and gastro-oesophageal junction adenocarcinoma
• Patients who have progressed after previous first-line treatment based on fluorouracil
• HER-2+ is known to have been previously trastuzumab or HER-2 negative
• According to RECIST1.1 criteria, the patient had at least one measurable target lesion
• Eastern Cooperative Oncology Group（ECOG）Physical status score: 0-2
• Absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelets ≥100×10\^9/L, and hemoglobin ≥90 g/L
• Serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal (≤5 times the upper limit of normal for patients with liver invasion); Total bilirubin ≤1.5 times the upper limit of normal (≤3 times the upper limit of normal for patients with liver invasion)
• There are no contraindications for the use of liposomal irinotecan and albumin paclitaxel
• Women of childbearing age must have had a pregnancy test (serological) negative within 7 days prior to enrollment and be willing to use an appropriate method of contraception during the trial
• Agree to provide histological samples

You may not qualify if:

• Allergic reaction to any investigational drug or its ingredients
• Patients with relapse within 6 months after previous first-line treatment with paclitaxel
• The investigational agent was a CYP3A4 strong inducer within 2 weeks prior to initial administration, or a CYP3A4 strong depressant or UGT1A1 strong depressant within 1 week
• Uncontrolled systemic diseases (e.g. advanced infections, uncontrolled hypertension, diabetes, etc.)
• Imaging confirmed intestinal obstruction
• It has uncontrollable ascites, abdominal infection and pyloric obstruction
• Hepatitis B, hepatitis C active infection (hepatitis B surface antigen positive and hepatitis B DNA more than 1x103 copies /mL; more than 1x103 copies /mL of HCV RNA)
• Human immunodeficiency virus (HIV) infection (HIV antibody positive)
• Previous or current co-occurrence of other malignancies (in addition to non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years)
• Pregnant and lactating women and patients of childbearing age who do not want to use contraception
• The investigators determined that patients were not suitable to participate in this study

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Liu zhenyang, Doctor

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu zhenyang, Doctor

CONTACT

18673181133; liuzhenyang@hnca.org.cn

Li rongrong, Doctor

CONTACT

13874822986

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 3, 2024
• Study Start: August 25, 2024
• Primary Completion: July 30, 2025
• Study Completion: January 30, 2026
• Last Updated: August 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF