AI-Assisted Treatment Planning for Gastrointestinal Cancer

Recruiting at 6 trial locations

Overseen By Di Dong, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Chinese Academy of Sciences

Disqualifiers: Non-GI cancers, Multiple hospitals, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the utility of ChatGPT in recommending treatment plans for patients with gastrointestinal cancers, using both retrospective and prospective data.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the AI-Assisted Treatment Planning for Gastrointestinal Cancer treatment?

The use of multidisciplinary team (MDT) discussions, which are part of the AI-Assisted Treatment Planning, has been shown to improve survival in patients with advanced gastrointestinal cancer, particularly colorectal cancer, by reducing the risk of death and increasing overall survival. ^{1 2 3 4 5}

Is AI-assisted treatment planning for gastrointestinal cancer safe for humans?

The available research does not provide specific safety data for AI-assisted treatment planning in humans, but it does explore the AI's ability to assist in treatment planning for cancer patients. ^{3 4 6 7 8}

How is the AI-Assisted Treatment Planning for Gastrointestinal Cancer unique compared to other treatments?

This treatment is unique because it uses artificial intelligence (AI) to assist in creating personalized treatment plans for gastrointestinal cancer, potentially improving decision-making by integrating complex data and providing recommendations that align with oncological principles, unlike traditional methods that rely solely on human expertise. ^{3 7 9 10 11}

Research Team

Di Dong, PhD

Principal Investigator

Institute of Automation, Chinese Academy of Sciences

Eligibility Criteria

This trial is for adults over 18 with a confirmed diagnosis of gastrointestinal cancer, specifically gastric or colorectal cancer. They must be treated at the participating hospitals and have detailed medical records available. It's not open to those treated across multiple hospitals or with different types of cancers.

Inclusion Criteria

I have been diagnosed with stomach or colorectal cancer.

I have all my medical records available from before starting treatment.

I will receive all my treatment at a participating hospital.

Exclusion Criteria

My cancer is not a gastrointestinal type.

Participants who receive treatment in multiple hospitals

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Retrospective Data Collection

Collection of medical records from over 1,200 patients with gastrointestinal cancers for exploratory and validation datasets

Not specified

Prospective Data Collection

Random allocation of 400 participants into control and ChatGPT-Assisted groups, followed by treatment plan recommendations and adjustments

Not specified

Follow-up

Participants are monitored for 3-year progression-free survival (PFS) and 5-year overall survival (OS) rates

5 years

Treatment Details

Interventions

• ChatGPT-Assisted Treatment Plan
• Clinician-Directed Treatment Plan

Trial Overview The study is testing how well ChatGPT can help doctors create treatment plans for gastrointestinal cancers compared to standard clinician-directed methods. It will use both past and current patient data to assess the effectiveness.

Participant Groups

Group I: GPT-Assisted Group Experimental Treatment 1 Intervention

In this arm, participants receive treatment plans from clinicians with the assistance of ChatGPT.

Group II: Control group Active Control 1 Intervention

In this arm, participants receive treatment plans directly from clinicians without the assistance of ChatGPT.

ChatGPT-Assisted Treatment Plan is already approved in European Union, United States for the following indications:

Approved in European Union as Lynparza for:

• Breast cancer
• Ovarian cancer
• Fallopian tube cancer
• Peritoneal cancer
• Pancreatic cancer
• Prostate cancer
• Endometrial cancer

Approved in United States as Lynparza for:

• Ovarian, fallopian tube, and primary peritoneal cancer
• Breast cancer
• Prostate cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

Chinese Academy of Sciences

Lead Sponsor

Trials

103

Recruited

34,050,000+

University Hospital Magdeburg, Germany

Collaborator

Trials

1

Recruited

400+

City of Hope Medical Center

Collaborator

Trials

614

Recruited

1,924,000+

San Raffaele University Hospital, Italy

Collaborator

Trials

34

Recruited

26,600+

Peking University Cancer Hospital (Inner Mongolia Campus)

Collaborator

Trials

1

Recruited

400+

Jiangmen Central Hospital

Collaborator

Trials

25

Recruited

28,500+

ZhuHai Hospital

Collaborator

Trials

23

Recruited

46,400+

Fifth Affiliated Hospital, Sun Yat-Sen University

Collaborator

Trials

102

Recruited

1,120,000+

Findings from Research

In a study of 153 patients with potentially curable upper gastrointestinal cancers, 41.8% did not adhere to multidisciplinary tumor board (MDT) recommendations, primarily due to patient refusal and treatment complications.

Non-adherent patients had significantly worse median overall survival (19.5 months) compared to adherent patients, indicating that following MDT recommendations may be crucial for improving oncological outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Multidisciplinary Tumor Board Recommendations in Patients With Curable Esophageal and Gastric Cancers. Soon, JJY., Zhao, Y., Shannon, NB., et al.[2023]

In a study of 330 patients with locally advanced oesophageal cancer, the 2-year survival rate for those receiving potentially curative treatment was 49%, with surgery alone showing the highest survival rates compared to other treatment combinations.

Definitive chemoradiotherapy (CRT) provided comparable overall survival to surgery alone for patients unfit for surgery, suggesting it is a viable alternative, although non-surgical therapies had a higher incidence of local relapses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective comparison of multidisciplinary treatment of oesophageal cancer with curative intent in a UK cancer network. Adams, R., Morgan, M., Mukherjee, S., et al.[2022]

In a preliminary analysis of 30 colorectal cancer cases, chatGPT™ demonstrated an 86.7% concordance rate with multidisciplinary tumor board recommendations, indicating its potential effectiveness in formulating oncological management plans.

The AI's recommendations adhered to oncological principles and considered patients' overall health and functional status, suggesting it could be a valuable tool in clinical decision-making for complex cancer cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conversational artificial intelligence (chatGPT™) in the management of complex colorectal cancer patients: early experience. Choo, JM., Ryu, HS., Kim, JS., et al.[2023]

The implementation of multidisciplinary team (MDT) decisions significantly improved overall survival (OS) for patients with advanced gastrointestinal cancer, with an OS of 24 months for those whose treatment followed MDT recommendations compared to 17 months for those who did not.

The study, which included 455 patients and was conducted across 13 medical centers in China, found that MDT discussions particularly benefited patients with colorectal cancer, highlighting the importance of timely follow-up discussions when patient conditions change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

China special issue on gastrointestinal tumors-Improved survival after multidisciplinary team decision for patients with advanced gastrointestinal cancer: A multicenter, noninterventional, controlled study. Zhang, Q., Zhou, Y., Song, L., et al.[2023]

The disease management program at M.D. Anderson Cancer Center involved nearly 1,000 patients and aimed to standardize care practices by developing evidence-based guidelines and collaborative care paths for different disease sites.

The program utilizes integrated information systems to implement guidelines in real-time patient care, which is expected to enhance care quality, support outcomes research, and reduce healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of guidelines and paths in oncology. Morris, M.[2007]

The Western Canadian Gastrointestinal Cancer Consensus Conference brought together a diverse group of healthcare professionals to discuss and develop recommendations for systemic therapy in patients with resectable metastatic colorectal cancer.

The conference aimed to optimize the sequence of treatments, highlighting the importance of collaboration among oncologists, pathologists, and other specialists in improving patient care for gastrointestinal cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic Therapy and Its Surgical Implications in Patients with Resectable Liver Colorectal Cancer Metastases. A Report from the Western Canadian Gastrointestinal Cancer Consensus Conference. Ahmed, S., Bosma, N., Moser, M., et al.[2022]

In a pilot study involving 10 breast cancer patients, ChatGPT provided general recommendations for treatment options but struggled with specific therapy recommendations, indicating its current limitations in clinical decision-making.

While ChatGPT could identify risk factors and suggest evaluations for treatment, it made errors in therapy recommendations, such as incorrectly suggesting antibody therapy for certain Her2 statuses, highlighting the need for caution in using AI for personalized patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating ChatGPT as an adjunct for the multidisciplinary tumor board decision-making in primary breast cancer cases. Lukac, S., Dayan, D., Fink, V., et al.[2023]

ChatGPT demonstrated a strong ability to identify appropriate systemic therapies for advanced solid cancers, achieving a valid therapy quotient (VTQ) of 0.77 when compared to the National Comprehensive Cancer Network (NCCN) guidelines, based on 51 distinct cancer diagnoses.

While ChatGPT consistently provided at least one recommended treatment for each cancer type, its exact role in aiding oncologists and patients in treatment decisions is still unclear, suggesting the need for further research to evaluate its effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capacity of ChatGPT to Identify Guideline-Based Treatments for Advanced Solid Tumors. Schulte, B.[2023]

Precision medicine in oncology faces challenges due to the complexity of decision-making, as human cognitive capacity is limited to considering only a few variables at a time, while there are many biomarkers and treatment options available.

Multifactorial decision support systems (DSSs) that utilize artificial intelligence can help overcome these limitations by integrating diverse data sources to predict outcomes and optimize treatment decisions, thereby improving efficacy and cost-effectiveness in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision Support Systems in Oncology. Walsh, S., de Jong, EEC., van Timmeren, JE., et al.[2020]

The study analyzed treatment recommendations for 302 breast cancer patients using IBM's Watson for Oncology (WFO), finding a 77% concordance rate for postoperative adjuvant therapy, indicating WFO's potential effectiveness in guiding treatment decisions.

However, the concordance dropped to 27.5% for metastatic cases, primarily due to differing chemotherapy regimen choices, highlighting the need for further adaptation of WFO to better suit the complexities of metastatic breast cancer treatment in Chinese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concordance between treatment recommendations provided by IBM Watson for Oncology and a multidisciplinary tumor board for breast cancer in China. Zhao, X., Zhang, Y., Ma, X., et al.[2020]

In a study involving 250 colorectal cancer patients, the treatment recommendations made by IBM's Watson for Oncology (WFO) showed a high concordance rate of 91% with those made by a multidisciplinary team, indicating strong agreement in treatment strategies.

Factors such as patient age, cancer stage, and previous therapies significantly influenced the concordance, suggesting that refining these aspects in AI systems could enhance their effectiveness in personalized cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificial Intelligence in Decision-Making for Colorectal Cancer Treatment Strategy: An Observational Study of Implementing Watson for Oncology in a 250-Case Cohort. Aikemu, B., Xue, P., Hong, H., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adherence to Multidisciplinary Tumor Board Recommendations in Patients With Curable Esophageal and Gastric Cancers. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A prospective comparison of multidisciplinary treatment of oesophageal cancer with curative intent in a UK cancer network. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Conversational artificial intelligence (chatGPT™) in the management of complex colorectal cancer patients: early experience. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

China special issue on gastrointestinal tumors-Improved survival after multidisciplinary team decision for patients with advanced gastrointestinal cancer: A multicenter, noninterventional, controlled study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Implementation of guidelines and paths in oncology. [2007]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Systemic Therapy and Its Surgical Implications in Patients with Resectable Liver Colorectal Cancer Metastases. A Report from the Western Canadian Gastrointestinal Cancer Consensus Conference. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Evaluating ChatGPT as an adjunct for the multidisciplinary tumor board decision-making in primary breast cancer cases. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Capacity of ChatGPT to Identify Guideline-Based Treatments for Advanced Solid Tumors. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Decision Support Systems in Oncology. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Concordance between treatment recommendations provided by IBM Watson for Oncology and a multidisciplinary tumor board for breast cancer in China. [2020]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Artificial Intelligence in Decision-Making for Colorectal Cancer Treatment Strategy: An Observational Study of Implementing Watson for Oncology in a 250-Case Cohort. [2022]