LDRT Combined With Immunochemotherapy for Colorectal Cancer With Liver Metastasis

NCT06848465 | Recruiting Phase 1

• 1 other identifier: DP2024348
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Colorectal Cancer; Liver Metastasis; LDRT

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events

  Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measurement of Safety and tolerability of LDRT in Combination With Tirellizumab and XELOX

  3 years

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  2 years

• Progression-free survival (PFS)

  2 years

• Overall survival (OS)

  3 years

Study Arms (1)

LDRT/LDRT+SCRT followed by Tislelizumab+XELOX

EXPERIMENTAL

For patients with colon Cancer: LDRT starts from day 1. For patients with rectal Cancer: LDRT and SCRT start concurrently from day 1. Tislelizumab+XELOX start from 1week after the completion of radiotherapy (2-4 cycles).

Radiation: Low Dose Radiotherapy; Radiation: Short course Radiotherapy; Drug: XELOX; Drug: Tislelizumab

Interventions

Low Dose Radiotherapy RADIATION

10 Gy in 5 fractions, 15 Gy in 3 fractions, 20 Gy in 10 fractions respectively in three Cohorts from Day1

LDRT/LDRT+SCRT followed by Tislelizumab+XELOX

Short course Radiotherapy RADIATION

25 Gy in 5 fractions from Day1

LDRT/LDRT+SCRT followed by Tislelizumab+XELOX

XELOX DRUG

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.

LDRT/LDRT+SCRT followed by Tislelizumab+XELOX

Tislelizumab DRUG

200mg IV Q3W on day 1 of each cycle.

LDRT/LDRT+SCRT followed by Tislelizumab+XELOX

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between18 and 75 years old.
• Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum.
• The clinical baseline stage of rectal cancer assessed by MRI/CT/Transrectal ultrasound was T3-4Nx or TXN1-2.
• Simultaneous liver metastasis confirmed by imaging examination.
• No previous antitumor treatment.
• An Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
• 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).
• Sign the informed consent and have good compliance.

You may not qualify if:

• Distant metastasis from other than the liver.
• 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).
• 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.
• 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.
• History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation.
• 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%).
• 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).
• Pregnant or lactating women.
• 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.

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

Study Sites (2)

Army Medical Center

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Daping Hospital, Army Medical University

Chongqing, Chongqing Municipality, 400042, China

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Radiotherapy; XELOX; tislelizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Chuan Chen, MD PhD

  Daping Hospital, Army Medical University

  STUDY DIRECTOR

Central Study Contacts

Chuan Chen, MD PhD

CONTACT

13883089634; sinkriver@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 27, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: May 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)