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

Sponsor
Jiangsu Cancer Institute & Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06045286
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
27.4
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Radiation: High- and Low-dose radiotherapy
  • Drug: PD-1 Inhibitors
 Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
High- and Low-dose Radiotherapy Combined With PD-1 Inhibitors for Microsatellite Stable (MSS) Colorectal Liver Metastases (CRLM)
Anticipated Study Start Date :
Sep 20, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: High- and Low-dose radiotherapy combined with immunotherapy.

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
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.

Outcome Measures

Primary Outcome Measures

  1. Objective response rate (ORR) [1,3,6, and 12 months after completion of radiotherapy]

    The proportion of patients showing complete or partial response of low-dose radiotherapy lesions and other metastatic lesions assessed by RECIST v1.1

Secondary Outcome Measures

  1. Progression-free survival (PFS) [12 months]

    From the start of treatment to the date of progression or death

  2. Overall survival (OS) [12 months]

    the time from the start of treatment to death from any cause

Other Outcome Measures

  1. Safety evaluation [12 months]

    NCI-CTCAE version 5.0 to assess adverse events (therapeutic toxicity)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jiangsu Cancer Hospital Nanjing Jiangsu China 210009

Sponsors and Collaborators

  • Jiangsu Cancer Institute & Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lijun Wang, Associate Professor, Jiangsu Cancer Institute & Hospital
ClinicalTrials.gov Identifier:
NCT06045286
Other Study ID Numbers:
  • HaRyPOT
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Lijun Wang, Associate Professor, Jiangsu Cancer Institute & Hospital
microsatellite stable
PD-1 Inhibitors
abscopal effects
Additional relevant MeSH terms:
Neoplasm Metastasis
Immune Checkpoint Inhibitors

Study Results

No Results Posted as of Sep 21, 2023