High- and Low-dose Radiotherapy Combined With PD-1 Inhibitors for MSS CRLM

Colorectal Liver Metastases Clinical Trial

— HaRyPOT  

Official title:

High- and Low-dose Radiotherapy Combined With PD-1 Inhibitors for Microsatellite Stable (MSS) Colorectal Liver Metastases (CRLM)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06045286
• Other study ID #: HaRyPOT
• Status: Recruiting
• Phase: Phase 1
• Start date: September 20, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Jiangsu Cancer Institute & Hospital
• Contact: Yuxuan Ding
• Phone: 18951590901
• Email: dyxoo99[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot phase I trial aims to investigate the efficacy and safety of high- and low-dose radiotherapy combined with programmed cell death-1 (PD-1) inhibitors in microsatellite stable (MSS) metastatic colorectal cancer (mCRC) that have failed second-line immunotherapy or above.

Description:

This pilot phase I trial aims to investigate the efficacy and safety of high- and low-dose radiotherapy combined with programmed cell death-1 (PD-1) inhibitors in microsatellite stable (MSS) metastatic colorectal cancer (mCRC) that have failed second-line immunotherapy or above. 30 participants will be enrolled in this study. All will take part at Jiangsu Cancer Hospital.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with microsatellite stable colorectal liver metastases and failure with second-line or above therapy, and no subsequent standard treatment regimen.

2. Patients with an ECOG score of 0 or 1, and an expected survival period of =6 months.

3. During the study, they are willing to follow the arrangement and not use other systemic anti-tumor drugs such as chemotherapy, targeted, Chinese herbal medicine, and proprietary Chinese medicine.

4. 18-70 years old, no gender limit.

Exclusion Criteria:

1. Those with a history of severe immediate allergy to the drugs used in this study.

2. Cancer patients who require urgent surgical intervention, such as high-risk pathological fractures, life-threatening bleeding symptoms, etc.

3. Any of the following conditions in the 6 months before screening: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient cerebral ischemia Onset or symptomatic pulmonary embolism. Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria or left ventricular ejection fraction <50% must adopt an optimized and stable medical plan determined by the treating doctor. If appropriate, you can consult a cardiologist.

4. Patients with active infection requiring systemic treatment.

Related Conditions & MeSH terms

• Colorectal Liver Metastases
• Neoplasm Metastasis

Intervention

Radiation:
• Radiation: High- and Low-dose radiotherapy
High-dose radiotherapy (6-8Gy×3-7F) followed by low-dose radiotherapy (0.5-1.4Gy×3-7F) starting within 7 days after completion.

Drug:
• PD-1 Inhibitors
Immunotherapy (Zimberelimab) is given every three weeks within one week after the end of high-dose radiotherapy.

Locations

Country	Name	City	State
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Cancer Institute & Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety evaluation	NCI-CTCAE version 5.0 to assess adverse events (therapeutic toxicity)	12 months
Primary	Objective response rate (ORR)	The proportion of patients showing complete or partial response of low-dose radiotherapy lesions and other metastatic lesions assessed by RECIST v1.1	1,3,6, and 12 months after completion of radiotherapy
Secondary	Progression-free survival (PFS)	From the start of treatment to the date of progression or death	12 months
Secondary	Overall survival (OS)	the time from the start of treatment to death from any cause	12 months