Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence

NCT06120127 | Unknown Phase 2

• 1 other identifier: FDRT-2023-258-3377
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled phase II trial to evaluate the efficacy of the combination of stereotactic body radiation therapy (SBRT) and immunotherapy with postoperative chemotherapy in colorectal cancer liver metastasis (CRLM) patients with high risk of locally recurrence. Researchers will compare the combination therapy with the postoperative chemotherapy alone to see if postoperative chemotherapy plus SBRT and immunotherapy can further reduce the risk of recurrence and metastasis after surgery.

Conditions

Radiotherapy; Immunotherapy; Liver Metastases; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Evaluate the effect of the combination of adjuvant chemotherapy, SBRT and immunotherapy versus observation on progression free survival

  From the date of randomization until the date of first documented progression or date of death from any cause, whichever come first, assessed up to 12 months

Secondary Outcomes (3)

• Local control rate

  From the date of randomization until the date of first documented locally tumor recurrence, assessed up to 12 months

• Overall survival

  From date of randomization until the date of death from any cause, assessed up to 36 months

• Grade 3-4 adverse effect rate

  From date of randomization until the date of death from any cause, assessed up to 3 years

Study Arms (2)

chemotherapy with radiotherapy and immunotherapy

EXPERIMENTAL

radiotherapy: SBRT of liver lesions; postoperative chemotherapy and immunotherapy: chemotherapy by investigators' choice with sintilimab for 18 weeks

Radiation: SBRT; Drug: Chemotherapy; Drug: PD-1 antibody

chemotherapy

ACTIVE COMPARATOR

postoperative chemotherapy: chemotherapy by investigators' choice for 18 weeks

Drug: Chemotherapy

Interventions

SBRT RADIATION

postoperative SBRT of liver lesions

Also known as: radiotherapy

chemotherapy with radiotherapy and immunotherapy

Chemotherapy DRUG

XELOX/FOLFOX/FOLFIRI

chemotherapy; chemotherapy with radiotherapy and immunotherapy

PD-1 antibody DRUG

Sintilimab (200mg d1，q3w)

Also known as: Sintilimab

chemotherapy with radiotherapy and immunotherapy

Eligibility Criteria

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

You may qualify if:

• age ≥ 18 years old, female and male
• pathological and imaging confirmed colorectal colorectal liver metastases (synchronous or heterochronous)
• Metastatic liver lesions \<= 5
• Primary colorectal cancer under control
• Absence of evidence of extra-hepatic diseases
• Metastatic liver lesions received resection with insufficient margin (\<0.5cm) or R1/R2 resection
• Karnofsky \>= 70
• Adequate organ function without contraindications to surgery, radiotherapy and immunotherapy
• Without previous antitumoral immunotherapy
• With good compliance
• Signed the inform consent

You may not qualify if:

• Pregnancy or breast-feeding women
• History of other malignancies within 5 years (except cured skin cancer and cervical cancer in situ)
• History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders
• Clinically serious heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months
• Immunodeficiency disease, autoimmune diseases or long-term using of immunosuppressive agents
• Severe uncontrolled recurrent infections
• Baseline blood and biochemical indicator do not meet the following criteria: neutrophils \>=1.5×10\^9/L, Hb \>=90g/L, PLT \>=100×10\^9/L, ALT/AST\<=2.5 ULN, Cr \<= 1ULN
• Allergic to any component of the therapy

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Radiotherapy; Drug Therapy; spartalizumab; sintilimab

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

• Fan Xia, M.D,PH.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fan Xia, M.D, PH.D

CONTACT

13564676623; tcxiafan@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: adjuvant radiotherapy: SBRT; immunotherapy: sintilimab chemotherapy: XELOX

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 7, 2023
• Study Start: September 25, 2023
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

CN (1)