NCT05747716

Brief Summary

The study is a phase II clinical study. The purpose of the study is to evaluate the efficacy and safety of SBRT combined with Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
8mo left

Started Feb 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Feb 2023Dec 2026

First Submitted

Initial submission to the registry

February 18, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

3.8 years

First QC Date

February 18, 2023

Last Update Submit

February 18, 2023

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    Progression free survival

    2 years

Secondary Outcomes (2)

  • Actuarial rate in-field local control

    2 years

  • Toxicities

    2 years

Study Arms (1)

SBRT, Fruquintinib, Cadonilimab

EXPERIMENTAL
Drug: SBRT, Fruquintinib, Cadonilimab

Interventions

SBRT, Fruquintinib, CadonilimabDRUG

Radiation: Stereotactic body radiationtherapy (SBRT) for metastatic sites (less than 5) Fruquintinib: 5mg, po, everyday; Cadonilimab: 10mg/kg, iv, q3w

SBRT, Fruquintinib, Cadonilimab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have biopsy proven unresectable MCRC.
  • Patients must have received first-line and second-line chemotherapy, and approved a progressive disease.
  • Age ≥ 18 years
  • Patients must have measurable disease at baseline.
  • Patients can have up to only 5 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by position-emission tomography (PET) scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of radiotherapy.
  • Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months.
  • Patients must have a Karnofsky Performance Scores (KPS) \>60 8. Aspartate aminotransferase, alanine aminotransferase \& Alkaline phosphates must be ≤ 2.5 times the upper limit of normal (ULN). Total bilirubin must be within the limit of normal.
  • \. Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm3. 10. Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN). 11. Females of childbearing potential should have a negative pregnancy test. 12. Patients who would be receiving radiation for lung lesions who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1 litre.
  • \. Patients must provide verbal and written informed consent to participate in the study.
  • \. Total bilirubin: within normal institutional limits

You may not qualify if:

  • Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
  • Patients with serious, uncontrolled, concurrent infection(s).
  • Significant weight loss (\>10%) in the prior 3 months.
  • Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers.
  • Patients with more than 5 discrete metastatic lesions.
  • Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
  • Unwillingness to participate or inability to comply with the protocol for the duration of the study.
  • Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

RadiosurgeryHMPL-013

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Tao Zhang

    Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenyu Lin

CONTACT

02785871982whxhlzy@hust.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2023

First Posted

February 28, 2023

Study Start

February 28, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 28, 2023

Record last verified: 2023-02

Locations

CN(1)