A Phase Ib Trial on the Safety and Feasibility of Low Dose Radiotherapy (LDRT) Combined With Immunochemotherapy for Colorectal Cancer With Liver-limited Metastasis

Plain English Summary

LDRT Combined With Immunochemotherapy for Colorectal Cancer With Liver Metastasis is a Phase 1 clinical trial sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University studying Colorectal Cancer, Liver Metastasis, LDRT. This trial tests a combination of low-dose radiation therapy, chemotherapy (XELOX), and immunotherapy (Tislelizumab) for patients with colorectal cancer that has spread to the liver. It is for adults aged 18-75 with newly diagnosed colorectal cancer that has spread only to the liver and who have not received prior cancer treatment. Participants will receive a combination of radiation, chemotherapy, and immunotherapy. The exact radiation dose and schedule will vary based on the treatment group. Standard treatments for colorectal cancer with liver metastasis include surgery, chemotherapy, targeted therapy, and radiation, depending on the extent of the disease. The trial aims to enroll 9 participants.

Official Summary

In recent years, growing evidences have demonstrated promising synergistic antitumor effects of radiotherapy combined with immunotherapy. More over, LDRT may enhance the antitumor effect of immunotherapy by altering the tumor immune microenvironment (TIME) and adjusting the immune response. In this study, we will explore the safety and feasibility of LDRT and immunochemotherapy in liver metastatic colorectal cancer. 9-18 participants will be enrolled in this study. All will take part at Daping Hospital, Army Medical University.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are between 18 and 75 years old, have confirmed colorectal cancer that has spread to the liver, and have not had any cancer treatment before. You cannot join if you have cancer spread to other parts of your body, have a BMI below 18.5, have certain autoimmune diseases, or have had recent heart problems. You must have good general health, including adequate heart, liver, kidney, and blood cell function. Women who are pregnant or breastfeeding cannot participate. This trial is studying Colorectal Cancer, Liver Metastasis, LDRT, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures the rate of side effects from the treatment over 3 years, indicating how safe this new combination therapy is. The specific primary outcome measures are: Incidence of treatment-emergent adverse events (3 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial explores a new combination therapy to potentially improve outcomes for patients with colorectal cancer that has spread to the liver, addressing a need for more effective treatment options. This research targets Colorectal Cancer, Liver Metastasis, LDRT, where improved treatment options are needed.

Investor Insight

This early-phase trial investigates a novel combination for a specific cancer subtype, signaling potential for future treatment advancements in a competitive oncology market. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific radiation doses and schedules, potential side effects, and how this treatment compares to standard options. Participation involves receiving radiation therapy, chemotherapy infusions, and oral chemotherapy. You will have regular check-ups and blood tests. The treatment duration and frequency of visits will depend on the specific treatment group you are assigned to. This trial is currently recruiting participants. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 9 participants

Interventions

• RADIATION: Low Dose Radiotherapy — 10 Gy in 5 fractions, 15 Gy in 3 fractions, 20 Gy in 10 fractions respectively in three Cohorts from Day1
• RADIATION: Short course Radiotherapy — 25 Gy in 5 fractions from Day1
• DRUG: XELOX — Oxaliplatin: 130mg/m2 IV Q3W on day 1 of each cycle. Capecitabine: 1000mg/m2 Q3W Dose of 1000mg/m2 on day 1-14 of each cycle.
• DRUG: Tislelizumab — 200mg IV Q3W on day 1 of each cycle.

Primary Outcomes

• Incidence of treatment-emergent adverse events (3 years)

Secondary Outcomes

• Objective Response Rate (ORR) (2 years)
• Progression-free survival (PFS) (2 years)
• Overall survival (OS) (3 years)

Full Eligibility Criteria

Inclusion Criteria:

1. Age between18 and 75 years old.
2. Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum.
3. The clinical baseline stage of rectal cancer assessed by MRI/CT/Transrectal ultrasound was T3-4Nx or TXN1-2.
4. Simultaneous liver metastasis confirmed by imaging examination.
5. No previous antitumor treatment.
6. An Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
7. Adequate cardiac function (Left Ventricular Ejection Fractions \> 50%), hepatic function (total serum bilirubin ≤ 1.5 × upper limit of normal, alanine aminotransferase or aspartate aminotransferase ≤ 2.5 × upper limit of normal), renal function (serum creatinine ≤ 1.5 × ULN or glomerular filtration rate \> 60 ml/min, based on Cockcroft-Gault), and hematopoietic function (white blood cells ≥ 4.0 × 109 cells per L, neutrophils ≥ 1.5 × 109 cells per L, hemoglobin ≥ 90 g/L, platelets ≥ 100 × 109 cells per L).
8. Sign the informed consent and have good compliance.

Exclusion Criteria:

1. Distant metastasis from other than the liver.
2. BMI \< 18.5 kg/m² or weight loss ≥ 10% within the past 6 months (with consideration of the impact of large amounts of pleural and ascitic fluid on body weight).
3. Received any of the following treatments: any investigational drug; enrolled in another clinical trial concurrently, unless it is an observational (non-interventional) clinical study; received anti-tumor vaccines or live vaccines.
4. Active autoimmune diseases, or a history of autoimmune diseases. A history of liver disease including, but not limited to HBV infection or HBV DNA positive(≥1×10\^4/ml), HCV infection or HCV DNA positive(≥1×10\^3/ml) and liver cirrhosis.
5. History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation.
6. A history of heart disease within 6 months (including congestive heart failure, acute myocardial infarction, severe/unstable angina, coronary artery bypass grafting, cardiac insufficiency ≥ NYHA grade 2 and LVEF\<50%).
7. The presence of a clinically detectable second primary malignancy, or history of other malignancies within 5 years excluding adequately treated non-melanoma skin cancer, carcinoma in situ of cervix and superficial bladder tumour (non-invasive tumour, or carcinoma in situ, or T1).
8. Pregnant or lactating women.
9. The investigator considers that the subject is not suitable to participate in this clinical study due to any clinical or laboratory abnormalities or compliance problems.

Trial Locations

• Army Medical Center, Chongqing, Chongqing Municipality, China
• Daping Hospital, Army Medical University, Chongqing, Chongqing Municipality, China

Frequently Asked Questions

Related Conditions

• Colorectal Cancer
• Liver Metastasis
• Gastrointestinal Stromal Tumors
• Hepatocellular Carcinoma
• Pancreatic Cancer
• Biliary Tract Cancer
• Oncology
• Radiation Oncology
• Medical Oncology
• Immunotherapy

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