Thalidomide Combined With Chemotherapy and Monotherapy for Maintenance Treatment for Her2-negative Advanced GC

January 17, 2022 updated by: Qilu Hospital of Shandong University

A Single-arm, Open, Prospective, Multi-center Study on Thalidomide Combined With First-line Chemotherapy and Monotherapy for Maintenance Treatment of Liver Metastases From Her2-negative Advanced Gastric Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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. Although immune checkpoint inhibitors have been approved for third-line treatment of advanced gastric cancer, they are expensive and poorly accessible. For patients with poor economic conditions, combination therapy based on chemotherapy regimen or treatment regimen optimization may still be a relatively important direction.

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.

In addition, the sedative effect of thalidomide helps to improve patients' sleep. Thalidomide can also inhibit inflammatory factors such as TNF-α, thus improving appetite and increasing lean body weight in patients with cachexia. Its antiemetic effects can reduce gastrointestinal reactions to chemotherapeutic drugs in combined therapy. Thalidomide is also very cheap in China, which is suitable for patients on long-term maintenance treatment. Therefore, it is of great significance to explore the therapeutic value of thalidomide in liver metastasis of advanced gastric cancer.

Study Type

Interventional

Enrollment (Anticipated)

106

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged 18-75 years old;
  2. ECOG physical status score 0-1 points (within 3 days before starting treatment);
  3. Expected survival period ≥ 3 months;
  4. Basically normal functions of major organs;
  5. 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;
  6. 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;
  7. 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);
  8. Measurable lesions assessed according to RECIST1.1;
  9. Able to swallow pills normally.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Thalidomide

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

Combined period：chemotherapy + T ：Thalidomide tablets: 100mg/d

Maintenance period: 100 mg/d, qn, orally. Sustained to disease progression or intolerable adverse reactions.

Other Names:
  • Fanyingting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival (PFS)
Time Frame: 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) ]
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (QOL)
Time Frame: UpUp to end of study (up to approximately 24 months)
EORTC QLQ-C30 (Version 3) Quality of life questionnaire will be used to assess the quality of life of the subjects.
UpUp to end of study (up to approximately 24 months)
Percentage of Participants With Adverse Events (AEs)
Time Frame: Up to end of study (up to approximately 24 months)
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Up to end of study (up to approximately 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 10, 2022

Primary Completion (ANTICIPATED)

March 10, 2024

Study Completion (ANTICIPATED)

December 10, 2024

Study Registration Dates

First Submitted

November 18, 2021

First Submitted That Met QC Criteria

January 17, 2022

First Posted (ACTUAL)

January 20, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 17, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOPE2021-Thal-AGC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer Metastatic to Liver

Clinical Trials on Thalidomide Combined With Chemotherapy and Monotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe