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

NCT06045286 | Unknown Phase 1

• 1 other identifier: HaRyPOT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Liver Metastases

Keywords

microsatellite stable; PD-1 Inhibitors; abscopal effects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression-free survival (PFS)

  12 months

• Overall survival (OS)

  12 months

Other Outcomes (1)

• Safety evaluation

  12 months

Study Arms (1)

High- and Low-dose radiotherapy combined with immunotherapy.

EXPERIMENTAL

All eligible patients will receive high-dose radiotherapy, followed by low-dose radiotherapy combined with PD-1 inhibitor therapy starting within 7 days after completion. The single dose of high-dose radiotherapy will be 6-8 Gy for 3-7 consecutive exposures, and the single dose of low-dose radiotherapy will be 0.5-1.4 Gy for 3-7 consecutive exposures.The PD-1 inhibitor (Zimberelimab) will be administered at the dose recommended in the specification every 3 weeks until disease progression, unacceptable toxicity, and withdrawal of informed consent by the patient.

Radiation: Radiation: High- and Low-dose radiotherapy; Drug: PD-1 Inhibitors

Interventions

Radiation: High- and Low-dose radiotherapy RADIATION

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

High- and Low-dose radiotherapy combined with immunotherapy.

PD-1 Inhibitors DRUG

Immunotherapy (Zimberelimab) is given every three weeks within one week after the end of high-dose radiotherapy.

High- and Low-dose radiotherapy combined with immunotherapy.

Eligibility Criteria

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

You may qualify if:

• Patients with microsatellite stable colorectal liver metastases and failure with second-line or above therapy, and no subsequent standard treatment regimen.
• Patients with an ECOG score of 0 or 1, and an expected survival period of ≥6 months.
• 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.
• years old, no gender limit.

You may not qualify if:

• Those with a history of severe immediate allergy to the drugs used in this study.
• Cancer patients who require urgent surgical intervention, such as high-risk pathological fractures, life-threatening bleeding symptoms, etc.
• 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.
• Patients with active infection requiring systemic treatment.

Sponsors & Collaborators

• Jiangsu Cancer Institute & Hospital: lead

Study Sites (1)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Interventions

Radiotherapy; Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Therapeutics; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Yuxuan Ding

CONTACT

18951590901; dyxoo99@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: September 20, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

CN (1)