NCT05198856

Brief Summary

The overall incidence of liver metastases from gastric cancer is about 9.9%-18.7%. Gastric cancer has strong heterogeneity and rapid disease progression, and the prognosis of liver metastasis is poor. The 5-year survival rate of patients with liver metastases from gastric cancer is very low, making clinical treatment challenging. Thalidomide has immunomodulatory and anti-angiogenesis effects. It has been used in the treatment of multiple myeloma for more than 20 years, and there are many clinical studies in solid tumors. In recent years, thalidomide has been found to induce the degradation of IKAROS family transcription factors IKZF1 and IKZF3 in combination with CRBN. Therefore, it is very meaningful to explore the therapeutic value of thalidomide in advanced gastric cancer liver metastasis.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2022

Typical duration for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
Last Updated

January 20, 2022

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

November 18, 2021

Last Update Submit

January 17, 2022

Conditions

Gastric Cancer Metastatic to Liver

Keywords

Thalidomidemaintenance treatmentgastric cancerliver metastases

Outcome Measures

Primary Outcomes (1)

  • progression-free survival (PFS)

    PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause whichever occurs first as determined by an IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).

    Randomization to the first occurrence of disease progression or death from any cause up to the clinical cut off date of March10,2024 (up to approximately 18 months) ]

Secondary Outcomes (2)

  • Quality of life (QOL)

    UpUp to end of study (up to approximately 24 months)

  • Percentage of Participants With Adverse Events (AEs)

    Up to end of study (up to approximately 24 months)

Study Arms (1)

Thalidomide

EXPERIMENTAL

The study is divided into two phases: The first phase is a combination phase (chemotherapy +T) : Oxaliplatin (130mg/m2 iv d1) and capecitabine (1000mg/m2 d1-14 po bid) repeated every 21 days for a total of 4-6 cycles. Thalidomide tablet: 100 mg/d, qn, orally. The second stage is maintenance stage: Patients who have obtained CR, PR or SD in the first stage enter the maintenance stage and receive maintenance treatment with thalidomide tablets: 100mg/d, qn, orally. Maintained until disease progression or adverse reactions are intolerable.

Drug: Thalidomide Combined With Chemotherapy and Monotherapy

Interventions

Thalidomide Combined With Chemotherapy and MonotherapyDRUG

Combined period：chemotherapy + T ：Thalidomide tablets: 100mg/d Maintenance period: 100 mg/d, qn, orally. Sustained to disease progression or intolerable adverse reactions.

Also known as: Fanyingting
Thalidomide

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-75 years old;
  • ECOG physical status score 0-1 points (within 3 days before starting treatment);
  • Expected survival period ≥ 3 months;
  • Basically normal functions of major organs;
  • Pathologically confirmed metastatic gastric cancer or adenocarcinoma at the gastroesophageal junction with no chance of radical surgery, accompanied by liver metastasis or simple liver metastasis;
  • No previous medical treatment; If neoadjuvant or adjuvant chemotherapy has been performed before and after surgery, recurrence can be defined as first-line therapy only after drug withdrawal for at least six months;
  • HER2 negative. HER2 negative definition: IHC (0 or 1+), or IHC (2+) but negative for FISH (HER2:CEP17\<2 with mean HER2 copy number \<4.0 signals/cell);
  • Measurable lesions assessed according to RECIST1.1;
  • Able to swallow pills normally.

You may not qualify if:

  • Those who are allergic to thalidomide;
  • Pregnant or lactating women;
  • Severe mental illness;
  • Those who cannot take medication or follow up as planned;
  • During the trial period and within 3 months after the trial, the subjects and their partners are not willing to use contraception;
  • Participants in other clinical studies 3 months prior to the trial；
  • Patients who are financially well off and willing to use immune checkpoint inhibitors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Riihimaki M, Hemminki A, Sundquist K, Sundquist J, Hemminki K. Metastatic spread in patients with gastric cancer. Oncotarget. 2016 Aug 9;7(32):52307-52316. doi: 10.18632/oncotarget.10740.

    PMID: 27447571BACKGROUND

  • Cheon SH, Rha SY, Jeung HC, Im CK, Kim SH, Kim HR, Ahn JB, Roh JK, Noh SH, Chung HC. Survival benefit of combined curative resection of the stomach (D2 resection) and liver in gastric cancer patients with liver metastases. Ann Oncol. 2008 Jun;19(6):1146-53. doi: 10.1093/annonc/mdn026. Epub 2008 Feb 27.

    PMID: 18304963BACKGROUND

  • Xiao Y, Zhang B, Wu Y. Prognostic analysis and liver metastases relevant factors after gastric and hepatic surgical treatment in gastric cancer patients with metachronous liver metastases: a population-based study. Ir J Med Sci. 2019 May;188(2):415-424. doi: 10.1007/s11845-018-1864-4. Epub 2018 Jul 30.

    PMID: 30062399BACKGROUND

  • Kang YK, Boku N, Satoh T, Ryu MH, Chao Y, Kato K, Chung HC, Chen JS, Muro K, Kang WK, Yeh KH, Yoshikawa T, Oh SC, Bai LY, Tamura T, Lee KW, Hamamoto Y, Kim JG, Chin K, Oh DY, Minashi K, Cho JY, Tsuda M, Chen LT. Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Dec 2;390(10111):2461-2471. doi: 10.1016/S0140-6736(17)31827-5. Epub 2017 Oct 6.

    PMID: 28993052BACKGROUND

  • Fuchs CS, Doi T, Jang RW, Muro K, Satoh T, Machado M, Sun W, Jalal SI, Shah MA, Metges JP, Garrido M, Golan T, Mandala M, Wainberg ZA, Catenacci DV, Ohtsu A, Shitara K, Geva R, Bleeker J, Ko AH, Ku G, Philip P, Enzinger PC, Bang YJ, Levitan D, Wang J, Rosales M, Dalal RP, Yoon HH. Safety and Efficacy of Pembrolizumab Monotherapy in Patients With Previously Treated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Clinical KEYNOTE-059 Trial. JAMA Oncol. 2018 May 10;4(5):e180013. doi: 10.1001/jamaoncol.2018.0013. Epub 2018 May 10.

    PMID: 29543932BACKGROUND

  • Zhou S, Wang F, Hsieh TC, Wu JM, Wu E. Thalidomide-a notorious sedative to a wonder anticancer drug. Curr Med Chem. 2013;20(33):4102-8. doi: 10.2174/09298673113209990198.

    PMID: 23931282BACKGROUND

  • Bartlett JB, Dredge K, Dalgleish AG. The evolution of thalidomide and its IMiD derivatives as anticancer agents. Nat Rev Cancer. 2004 Apr;4(4):314-22. doi: 10.1038/nrc1323. No abstract available.

    PMID: 15057291BACKGROUND

  • Stewart AK. Medicine. How thalidomide works against cancer. Science. 2014 Jan 17;343(6168):256-7. doi: 10.1126/science.1249543.

    PMID: 24436409BACKGROUND

  • Mantovani G, Maccio A, Madeddu C, Serpe R, Massa E, Dessi M, Panzone F, Contu P. Randomized phase III clinical trial of five different arms of treatment in 332 patients with cancer cachexia. Oncologist. 2010;15(2):200-11. doi: 10.1634/theoncologist.2009-0153. Epub 2010 Feb 15.

    PMID: 20156909BACKGROUND

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Xiuwen Wang, MD. PhD

CONTACT

+86 13791123979wangxiuwen@medmail.com.cn

Cuihua Yi, MD. PhD

CONTACT

+86 18560082871yicuihua@sdu.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2021

First Posted

January 20, 2022

Study Start

March 10, 2022

Primary Completion

March 10, 2024

Study Completion

December 10, 2024

Last Updated

January 20, 2022

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share