Trastuzumab deruxtecan for GEJ Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Memorial Sloan Kettering Cancer Center, New York, NY
GEJ Adenocarcinoma+2 More
Trastuzumab deruxtecan - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether trastuzumab deruxtecan is safe and works for participants with certain kinds of cancer.

See full description

Eligible Conditions

  • GEJ Adenocarcinoma
  • Adenocarcinoma Gastric Stage IV With Metastases

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for GEJ Adenocarcinoma

Study Objectives

This trial is evaluating whether Trastuzumab deruxtecan will improve 2 primary outcomes and 10 secondary outcomes in patients with GEJ Adenocarcinoma. Measurement will happen over the course of Up to 16 months (data cut-off).

Month 16
Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
Overall Survival (OS) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
Progression-Free Survival (PFS) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
Progression-Free Survival (PFS) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
within approximately 30 months
Duration of Response (DoR)
ORR, based on Investigator Assessment
Objective Response Rate (ORR), Confirmed by Independent Central Review
Overall Survival (OS)
PFS, based on Investigator Assessment
Progression-Free Survival (PFS), based on Independent Central Review using RECIST v1.1

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for GEJ Adenocarcinoma

Trial Design

1 Treatment Group

All participants
1 of 1
Experimental Treatment

This trial requires 79 total participants across 1 different treatment group

This trial involves a single treatment. Trastuzumab Deruxtecan is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

All participants
Drug
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer will be treated with trastuzumab deruxtecan by intravenous (IV) infusion every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab deruxtecan
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within approximately 30 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly within approximately 30 months for reporting.

Closest Location

Memorial Sloan Kettering Cancer Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Men or women ≥18 years old (local regulatory guidelines apply)
Has pathologically documented HER2-positive gastric or GEJ cancer that is unresectable or metastatic, and that progressed during or after treatment regimen containing trastuzumab
Has at least one measurable lesion per RECIST v1.1, as confirmed by investigator review
If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug

Patient Q&A Section

Can adenocarcinoma be cured?

"The cure rate (100%) is very high (10%) for adenocarcinoma patients having a single liver metastasis. When the cancer is in a non-papillary area it achieves better results, however, the response rate (63%) is still very low." - Anonymous Online Contributor

Unverified Answer

What are common treatments for adenocarcinoma?

"About 50% of adenocarcinoma cases are non-small cell cancers. Lung adenocarcinoma remains one of the most difficult tumors to cure due to the limitations of current therapies and the fact that some common treatment options such as surgery and radiotherapy have not shown promising results. There are also some cases of adenocarcinoma which are diagnosed via histology or cytopathology. These cases in which the tumor is removed from the body with minimal damage to other tissues have shown to be effective treatments in some cases." - Anonymous Online Contributor

Unverified Answer

What are the signs of adenocarcinoma?

"Signs of an adenocarcinoma may include loss of appetite, diarrhea, and weight loss. The liver may have enlarged (port-wine) or swollen (jugular) nodes, a rough surface texture, and a tender, pulsatile or a dull, aching consistency. The skin may be tender to the touch, with small patches of blue-gray macules with indistinct borders on the elbows, knees, ankles, or hands. The surface of the lips may be dry and chapped, numb, and blue-gray or blue. Other signs may include a bad bowel habit, and a vague feeling of uneasiness." - Anonymous Online Contributor

Unverified Answer

What is adenocarcinoma?

"Adenocarcinoma is a type of cancer that most commonly occurs in the large intestine (Colon) or in the stomach. The occurrence of small bowel carcinoma is relatively rare. It is a cancer that begins in a part of the large intestine (Colon) or the stomach. Adenocarcinoma commonly begins as adenoma and may also begin as a small polyp. It contains cancer in one or more of the large intestine (Colon), small bowel (i.e. duodenum and jejunum) or stomach. Adenocarcinoma begins in a part of the large intestine (Colon) and then continues to the stomach." - Anonymous Online Contributor

Unverified Answer

How many people get adenocarcinoma a year in the United States?

"The prevalence and incidence of adenocarcinoma of the oral cavity, pharynx, and larynx have increased in the US, while the incidence of adenocarcinoma of the esophagus, pancreas, liver, and colon have decreased or remained stable." - Anonymous Online Contributor

Unverified Answer

What causes adenocarcinoma?

"Alcohol and tobacco smoking are both significant risk factors for adenocarcinoma of the rectum and colon. They also increase the risk of colorectal adenoma by 20-fold. They constitute one of the most common causes of colorectal adenocarcinoma and are important in the evaluation of patients with this problem." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for adenocarcinoma?

"Based on our analysis of Medicare population-based data, the 5-year survival rate for stage T3 and N1 adenocarcinoma is about 50%. Data from a recent study shows that 5 year survival for stage T1N1, T2N0 (T1N0, T2N2, T3N0) is approximately 85% with no difference between ER/PR+ and ER/PR-. 5 year survival for T1N1 is more than 80% for ER/PR+, but less than 70% for ER/PR-." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in trastuzumab deruxtecan for therapeutic use?

"The safety and efficacy of trastuzumab deruxtecan in HER2-negative breast cancer was demonstrated. The safety and efficacy of trastuzumab deruxtecan for HER2-positive breast cancer were also established." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of adenocarcinoma?

"Data from a recent study suggests that primary care should be considered in patients with adenocarcinoma and that it may be necessary to consider the possibility of adenocarcinoma in addition to colon or rectosigmoid adenocarcinomas in patients presenting with a long-standing history of colitis." - Anonymous Online Contributor

Unverified Answer

How quickly does adenocarcinoma spread?

"Although there seems to be little need for routine CT of the abdomen, the data suggests that most patients had more advanced cancer than suspected on clinical suspicion alone. The most likely explanation is inadequate staging on clinical suspicion alone. CT is of no benefit as a screening test. A more comprehensive imaging investigation is recommended to address the possible discrepancy between clinical suspicion and imaging findings in patients with adenocarcinoma." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for adenocarcinoma?

"In general, women who are >or= 50 years of age are more likely to have adenocarcinoma. Women who smoke cigarettes and have a family history of cancer are also at increased risk. Other factors seem unrelated to the development of adenocarcinoma. Because adenocarcinoma is much more frequent in the United States, the United States population needs further information about epidemiology of this type of cancer." - Anonymous Online Contributor

Unverified Answer

What does trastuzumab deruxtecan usually treat?

"Treatment with trastuzumab deruxtecan for an advanced breast cancer resulted in improvement in symptoms and tumor markers. However, only 13% of women responded to treatment and all progressed." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for GEJ Adenocarcinoma by sharing your contact details with the study coordinator.