RadiotherapyPhase 2IMPROVENCT06120127
Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence
A Phase 2 study testing SBRT, Chemotherapy and PD-1 antibody in people with Radiotherapy and Immunotherapy, run by Fudan University at 1 site in China.
Trial summary
This study is a randomized controlled phase II trial to evaluate the efficacy of the combination of stereotactic body radiation therapy (SBRT) and immunotherapy with postoperative chemotherapy in colorectal cancer liver metastasis (CRLM) patients with high risk of locally recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy, Immunotherapy, Liver Metastases
- What is being tested?
- SBRT, Chemotherapy and PD-1 antibody
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2023to 25 Sep 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years old, female and male
- pathological and imaging confirmed colorectal colorectal liver metastases (synchronous or heterochronous)
- Metastatic liver lesions <= 5
- Primary colorectal cancer under control
- Absence of evidence of extra-hepatic diseases
- Metastatic liver lesions received resection with insufficient margin (<0.5cm) or R1/R2 resection
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- Karnofsky >= 70
- Adequate organ function without contraindications to surgery, radiotherapy and immunotherapy
- Without previous antitumoral immunotherapy
- With good compliance
- Signed the inform consent
Who cannot join
- Pregnancy or breast-feeding women
- History of other malignancies within 5 years (except cured skin cancer and cervical cancer in situ)
- History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders
- Clinically serious heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months
- Immunodeficiency disease, autoimmune diseases or long-term using of immunosuppressive agents
- Severe uncontrolled recurrent infections
- Baseline blood and biochemical indicator do not meet the following criteria: neutrophils >=1.5×10^9/L, Hb >=90g/L, PLT >=100×10^9/L, ALT/AST<=2.5 ULN, Cr <= 1ULN
- Allergic to any component of the therapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xia Fan, M.D, PH.D, 13564676623, tcxiafan@hotmail.com
About this study
Official title: Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence: A Randomized Controlled Phase II Trial
This study is a randomized controlled phase II trial to evaluate the efficacy of the combination of stereotactic body radiation therapy (SBRT) and immunotherapy with postoperative chemotherapy in colorectal cancer liver metastasis (CRLM) patients with high risk of locally recurrence. Researchers will compare the combination therapy with the postoperative chemotherapy alone to see if postoperative chemotherapy plus SBRT and immunotherapy can further reduce the risk of recurrence and metastasis after surgery.
Read the detailed description
40-50% of colorectal cancer patients have metastases at the time of diagnosis, of which liver metastases are the most common. Surgical resection is the most likely cure for CRLM patients, however, more than 50% of patients will experience recurrence within 2 years after resection of liver metastases. SBRT can be an effective and safe treatment modality, which can not only provide better local control of metastatic lesions, but also has a sensitizing immunotherapeutic effect. SBRT can effectively synergize with anti-PD-1/PD-L1 antibodies to activate the immune microenvironment of CRLM patients and improve survival. However, in CRLM patients after surgery, whether combining SBRT, immunotherapy and adjuvant chemotherapy results in better survival than chemotherapy alone, the evidence is insufficient.
- Conditions
- Radiotherapy, Immunotherapy, Liver Metastases, Colorectal Cancer
- Being tested
- SBRT, Chemotherapy, PD-1 antibody
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Also called radiotherapy
postoperative SBRT of liver lesions
ChemotherapyDrug
XELOX/FOLFOX/FOLFIRI
PD-1 antibodyDrug
Also called Sintilimab
Sintilimab (200mg d1，q3w)
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy with radiotherapy and immunotherapy | Experimental | radiotherapy: SBRT of liver lesions; postoperative chemotherapy and immunotherapy: chemotherapy by investigators' choice with sintilimab for 18 weeks Receives: Radiation: SBRT; Drug: Chemotherapy; Drug: PD-1 antibody |
| chemotherapy | Active comparator | postoperative chemotherapy: chemotherapy by investigators' choice for 18 weeks Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Evaluate the effect of the combination of adjuvant chemotherapy, SBRT and immunotherapy versus observation on progression free survival
Measured: From the date of randomization until the date of first documented progression or date of death from any cause, whichever come first, assessed up to 12 months
Secondary outcomes (3)
Local control rate
To evaluate local control rate after the combination of adjuvant chemotherapy, SBRT and immunotherapy in comparison to observation alone
Measured: From the date of randomization until the date of first documented locally tumor recurrence, assessed up to 12 months
Overall survival
To evaluate overall survival after the combination of adjuvant chemotherapy, SBRT and immunotherapy in comparison to observation alone
Measured: From date of randomization until the date of death from any cause, assessed up to 36 months
Grade 3-4 adverse effect rate
Rate of chemotherapy, SBRT and immunotherapy related adverse events
Measured: From date of randomization until the date of death from any cause, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start25 Sep 2023
- Primary completion25 Sep 2025 (estimated)
- Study completion25 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- adjuvant radiotherapy: SBRT; immunotherapy: sintilimab chemotherapy: XELOX
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Wang, MD, PhD, Fudan University
- Investigators
- Fan Xia, M.D,PH.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120127
- Sponsor's protocol ID
- FDRT-2023-258-3377
- Acronym
- IMPROVE
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence: A Randomized Controlled Phase II Trial
- ClinicalTrials.gov ID
- NCT06120127
- Acronym / sponsor ID
- IMPROVE / FDRT-2023-258-3377
- Conditions
- Radiotherapy, Immunotherapy, Liver Metastases, Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 25 Sep 2025 (estimated)
- Study completion
- 25 Sep 2025 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized controlled phase II trial to evaluate the efficacy of the combination of stereotactic body radiation therapy (SBRT) and immunotherapy with postoperative chemotherapy in colorectal cancer liver metastasis (CRLM) patients with high risk of locally recurrence. Researchers will compare the combination therapy with the postoperative chemotherapy alone to see if postoperative chemotherapy plus SBRT and immunotherapy can further reduce the risk of recurrence and metastasis after surgery.
Detailed description
40-50% of colorectal cancer patients have metastases at the time of diagnosis, of which liver metastases are the most common. Surgical resection is the most likely cure for CRLM patients, however, more than 50% of patients will experience recurrence within 2 years after resection of liver metastases. SBRT can be an effective and safe treatment modality, which can not only provide better local control of metastatic lesions, but also has a sensitizing immunotherapeutic effect. SBRT can effectively synergize with anti-PD-1/PD-L1 antibodies to activate the immune microenvironment of CRLM patients and improve survival. However, in CRLM patients after surgery, whether combining SBRT, immunotherapy and adjuvant chemotherapy results in better survival than chemotherapy alone, the evidence is insufficient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- adjuvant radiotherapy: SBRT; immunotherapy: sintilimab chemotherapy: XELOX
| Arm | Type | Receives |
|---|---|---|
| chemotherapy with radiotherapy and immunotherapy | Experimental | Radiation: SBRT, Drug: Chemotherapy, Drug: PD-1 antibodyradiotherapy: SBRT of liver lesions; postoperative chemotherapy and immunotherapy: chemotherapy by investigators' choice with sintilimab for 18 weeks |
| chemotherapy | Active comparator | Drug: Chemotherapypostoperative chemotherapy: chemotherapy by investigators' choice for 18 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- age ≥ 18 years old, female and male
- pathological and imaging confirmed colorectal colorectal liver metastases (synchronous or heterochronous)
- Metastatic liver lesions <= 5
- Primary colorectal cancer under control
- Absence of evidence of extra-hepatic diseases
Key exclusion criteria (8 listed)
- Pregnancy or breast-feeding women
- History of other malignancies within 5 years (except cured skin cancer and cervical cancer in situ)
- History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders
- Clinically serious heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months
- Immunodeficiency disease, autoimmune diseases or long-term using of immunosuppressive agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRTAlso: radiotherapypostoperative SBRT of liver lesions | Radiation | chemotherapy with radiotherapy and immunotherapy |
| ChemotherapyXELOX/FOLFOX/FOLFIRI | Drug | chemotherapy, chemotherapy with radiotherapy and immunotherapy |
| PD-1 antibodyAlso: SintilimabSintilimab (200mg d1，q3w) | Drug | chemotherapy with radiotherapy and immunotherapy |
Primary outcome
Progression free survival
Time frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever come first, assessed up to 12 months
Evaluate the effect of the combination of adjuvant chemotherapy, SBRT and immunotherapy versus observation on progression free survival
3 secondary outcomes
Local control rate
Time frame: From the date of randomization until the date of first documented locally tumor recurrence, assessed up to 12 months
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months
Grade 3-4 adverse effect rate
Time frame: From date of randomization until the date of death from any cause, assessed up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fan Xia, M.D,PH.D principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SBRT, Chemotherapy and PD-1 antibody in people with Radiotherapy and Immunotherapy, 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 11 inclusion and 8 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 7 Nov 2023. 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 Fan Xia, M.D, PH.D (13564676623 ext. 13564676623, tcxiafan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever come first, assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2023.