What side effects are associated with this type of intervention?

Common treatments for cholangiocarcinoma, such as gemcitabine and cisplatin, often cause side effects including nausea, vomiting, fatigue, and myelosuppression (reduced bone marrow activity leading to fewer blood cells). When combined with other agents like nab-paclitaxel or targeted therapies such as cetuximab, additional side effects may include skin rash, diarrhea, and infusion-related reactions. Novel agents and combinations being studied in clinical trials may also present unique side effects, but the primary focus remains on managing the tolerability and safety of these treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for cholangiocarcinoma, particularly focusing on advanced stages of the disease. Standard chemotherapy regimens often include gemcitabine and cisplatin. Targeted therapies, such as erlotinib, have been explored in combination with chemotherapy, although their efficacy remains under investigation. More recently, immunotherapy agents like pembrolizumab have been approved for use in patients with specific genetic markers. The ongoing trial aims to evaluate a new drug that could potentially enhance the effectiveness of these standard treatments, offering hope for improved outcomes in patients with advanced cholangiocarcinoma.

What other types of research exist?

Promising novel alternatives for cholangiocarcinoma patients in 2024 include: 1) Durvalumab combined with gemcitabine and cisplatin, which has shown efficacy in advanced biliary tract cancer. 2) Combination therapies involving gemcitabine plus oxaliplatin (GEMOX) or gemcitabine plus S-1, which have demonstrated effectiveness in clinical trials. 3) Antiangiogenic therapies such as bevacizumab combined with chemotherapy (e.g., FOLFIRI) for advanced cases. These alternatives offer potential benefits in terms of progression-free survival and overall response rates.

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LSTA1 + Standard Care for Advanced Cancers (BOLSTER Trial)

Phase 2

Recruiting

Research Sponsored by Lisata Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after treatment discontinuation

Summary

This trial is testing a new drug called LSTA1 combined with standard treatment in patients with advanced cholangiocarcinoma. It aims to find out if this combination is safer and more effective than the standard treatment alone.

Who is the study for?

This trial is for adults with advanced head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, or cholangiocarcinoma. They must have progressed after first-line therapy, be expected to live at least 3 months, have good organ function and performance status. Exclusions include recent major surgery or radiation, active infections including hepatitis B/C or HIV, certain autoimmune diseases, other cancers treated within the last 3 years, significant heart disease within the past 6 months.

What is being tested?

The study tests a new drug called LSTA1 added to standard cancer treatments (like Gemcitabine and Cisplatin) versus just the standard treatments alone. It aims to find out if adding LSTA1 is safe and improves outcomes compared to standard care in patients with specific types of advanced solid tumors.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as inflammation in different body parts due to Durvalumab (an immunotherapy), plus typical chemotherapy side effects like nausea, fatigue, hair loss from drugs like Docetaxel and Paclitaxel.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after treatment discontinuation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after treatment discontinuation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after treatment discontinuation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: LSTA1 arm for Untreated CholangiocarcinomaExperimental Treatment4 Interventions

Group II: LSTA1 arm for Second-Line CholangiocarcinomaExperimental Treatment2 Interventions

Group III: Placebo arm for Second-Line CholangiocarcinomaPlacebo Group2 Interventions

Group IV: Placebo arm for Untreated CholangiocarcinomaPlacebo Group4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FOLFOX regimen

2009

Completed Phase 3

~2440

Cisplatin

2013

Completed Phase 3

~3120

Durvalumab

2017

Completed Phase 2

~3750

Gemcitabine

2017

Completed Phase 3

~1920

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cholangiocarcinoma include chemotherapy, targeted therapy, and radiation therapy. Chemotherapy drugs like gemcitabine and cisplatin work by damaging the DNA of cancer cells, preventing them from dividing and growing. Targeted therapies, such as FGFR inhibitors, block specific molecules involved in cancer cell growth and survival. Radiation therapy uses high-energy rays to kill cancer cells or shrink tumors. These treatments are crucial for cholangiocarcinoma patients as they aim to control tumor growth, alleviate symptoms, and improve survival rates. The new drug being studied in the trial is designed to enhance the effectiveness of standard treatments, potentially offering better outcomes by making cancer cells more susceptible to these therapies.