AzTrials
AzTrials

Microsatellite Stable Metastatic Colorectal CancerPhase 2SLOTNCT05963490

Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer

A Phase 2 study testing Regorafenib, Toripalimab and Radiotherapy in people with Microsatellite Stable Metastatic Colorectal Cancer, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The study compares the efficacy and safety of regorafenib alone or in combination with hypofractionated radiotherapy and low-dose radiotherapy (LDRT) plus toripalimab in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC). Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Regorafenib, Toripalimab and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteChina
Study dates
25 Apr 2023to 25 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years old
  • An Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Life expectancy of at least 3 months
  • Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum
  • At least one evaluable metastatic lesion for radiotherapy according to RECIST 1.1
  • Progressed on or after the standard first-and second-line therapies or stopped standard therapy because of unacceptable toxic effects
Show all 9Show fewer
  • Previous radiotherapy completed at least 4 weeks before randomization
  • Adequate bone-marrow, hepatic, and renal function: neutrophils ≥ 1.5 × 10^9/L, Hb ≥ 90 g/L, PLT ≥ 100 × 10^9/L, ALT/ AST≤2.5 ULN, Cr≤1 ULN
  • Sign the informed consent and have good compliance

Who cannot join

  • History of previous treatment with regorafenib and ICIs such as anti-PD-1 or anti-PD-L1 mAbs
  • Current severe cardiovascular diseases such as unstable angina, congestive heart failure, or serious cardiac arrhythmia requiring medication
  • Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment
  • Active autoimmune diseases and immunodeficiencies, known history of organ transplantation, or systematic use of immunosuppressive agents
  • Active Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection: HBsAg positive or HBV DNA positive, anti-HCV antibody testing positive and confirmatory HCV RNA positive
  • Positive human immunodeficiency virus (HIV) infection, active syphilis infection, or active pulmonary tuberculosis infection
Show all 12Show fewer
  • Severe infections requiring systemic antibiotics, antifungal or antiviral therapy
  • Uncontrollable pleural effusion, pericardial effusion, or ascites
  • Other malignancies within 5 years before recruitment, except for non-melanoma skin cancer, superficial bladder cancer, cervical carcinoma in situ, or breast cancer in situ that had been effectively treated.
  • Known history of severe neurological or mental illness such as schizophrenia, dementia, or epilepsy
  • Known history of allergy to any component involved in this study.
  • Pregnancy or breast-feeding women

Trial locations and contacts

1 site in 1 country.

Zhen Zhang, MD, PHD contact

18801735029

zhen_zhang@fudan.edu.cn

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai

    Zhen Zhang, MD, PHD, 18801735029, zhen_zhang@fudan.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Randomized, Controlled Phase II Trial of Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab as Third-line Treatment in Patients With Metastatic Colorectal Cancer

The study compares the efficacy and safety of regorafenib alone or in combination with hypofractionated radiotherapy and low-dose radiotherapy (LDRT) plus toripalimab in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC). Patients are randomly assigned (1:1) into the control arm and the experimental arm. Control arm: a total of 54 patients will receive regorafenib monotherapy. Experimental arm: a total of 54 patients will first receive 1 cycle of regorafenib and toripalimab followed by hypofractionated/low-dose radiotherapy. Regorafenib and toripalimab will be continued after the completion of radiotherapy. The survival benefits, response rates, and adverse effects will be analyzed.

Read the detailed description

Control arm: regorafenib 120 mg orally once daily on days 1-21 of each 28 days cycle.

Experimental arm: regorafenib is administered 80 mg once daily on days 1-21 of each 28 days cycle with intravenous toripalimab 240 mg every 3 weeks. Radiotherapy regimes include hypofractionated radiotherapy (5 fractions of 4-12Gy) and low-dose radiotherapy (5 fractions of 0.5-2Gy).

Being tested
Regorafenib, Toripalimab, Radiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RegorafenibDrug

    Also called Stivarga

    Regorafenib 120 mg orally once daily on days 1-21 of each 28 days cycle.

  • ToripalimabDrug

    240 mg intravenously every 3 weeks

  • RadiotherapyRadiation

    hypofractionated radiotherapy (5 fractions of 4-12Gy) and low-dose radiotherapy (5 fractions of 0.5-2Gy).

  • RegorafenibDrug

    Regorafenib 80mg orally once daily on days 1-21 of each 28 days cycle.

Study groups in NCT05963490
Study groupRoleWhat they receive
monotherapyActive comparatora total of 54 patients will receive regorafenib monotherapy.
Receives: Drug: Regorafenib
combination therapiesExperimentala total of 54 patients will first receive 1 cycle of regorafenib and toripalimab followed by hypofractionated/low-dose radiotherapy. Regorafenib and toripalimab will be continued after the completion of radiotherapy.
Receives: Drug: Toripalimab; Radiation: Radiotherapy; Drug: Regorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OS

    Defined as the time from initiation of treatment to death from any cause.

    Measured: Up to 2 years

Secondary outcomes (5)

  1. PFS

    Defined as the time from initiation of treatment to PD or death from any cause.

    Measured: Up to 2 years

  2. DCR

    The percentage of patients with disease control in all metastatic lesions. Disease control is defined as CR, PR, or stable disease (SD) per RECIST v1.1 and iRECIST after treatment.

    Measured: Up to 1 year

  3. ORR

    The percentage of patients with objective response in all metastatic lesions.

    Measured: Up to 1 year

  4. DoR

    Defined as the time between PR/CR and subsequent progression disease (PD) per RECIST v1.1 and iRECIST or death from any cause.

    Measured: Up to 1 year

  5. Adverse events

    The percentage of patients with treatment-related acute toxicities as assessed by NCI CTCAE v5.0, from treatment initiation until 90 days upon completion of immunotherapy.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start25 Apr 2023
  3. Primary completion25 Apr 2025 (estimated)
  4. Study completion25 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05963490
Sponsor's protocol ID
FDRT-2023-118-3237
Acronym
SLOT
Status last verified
Sep 2024
First submitted
19 Jul 2023
Last updated
24 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhou S, Wang C, Shen L, Wang Y, Zhang H, Wu R, Wang Y, Chen Y, Xuan Y, Xia F, Zhang Z, Wan J. Regorafenib alone or in combination with high/low-dose radiotherapy plus toripalimab as third-line treatment in patients with metastatic colorectal cancer: protocol for a prospective, randomized, controlled phase II clinical trial (SLOT). Front Oncol. 2023 Oct 5;13:1274487. doi: 10.3389/fonc.2023.1274487. eCollection 2023.

    PubMed 37869085

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Regorafenib, Toripalimab and Radiotherapy in people with Microsatellite Stable Metastatic Colorectal Cancer, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhen Zhang, MD, PHD (18801735029, zhen_zhang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OS (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05963490, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in