Colorectal CancerPhase 2NCT05799443
Efficacy and Safety of SBRT Followed by Tislelizumab Plus Cetuximab and Irinotecan in Patients With Previously Treated RAS Wild-type Advanced Refractory Colorectal Cancer
A Phase 2 study testing Tislelizumab, Irinotecan Hydrochloride and cetuximab in people with Colorectal Cancer, run by Fujian Cancer Hospital.
Trial summary
To evaluate the efficacy and safety of SBRT followed by tislelizumab plus cetuximab and irinotecan in patients with previously treated RAS wild-type advanced refractory colorectal cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Tislelizumab, Irinotecan Hydrochloride and cetuximab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2023to 5 Apr 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years
- Physical Condition Score (ECOG PS) of the Eastern Cancer Cooperative Group (USA) 0 or 1;
- Colorectal cancer diagnosed histologically and/or cytologically has metastases or relapses that are not curable by surgery
- Have received first - and second-line systemic antitumor therapy for mCRC (chemotherapy drugs may include fluorouracil, oxaliplatin, irinotecan, e.g. XELOX, FOLFOX, FOLFIRI, FOLFOXIRI, XELIRI; Can be combined with or without targeted drugs, such as cetuximab, bevacizumab);And disease progression after second-line treatment;
- Evaluation of lung or liver metastases can be evaluated, with stereotactic radiotherapy maneuverability;
- At least one measurable lesion as defined in RECIST version 1.1;
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- Fertile patients must be willing to take effective pregnancy avoidance measures during the study period and ≥120 days after the last dose; Female patients with negative urine or serum pregnancy test results within 7 days or less before the first administration of the study drug;
- Have fully understood this study and voluntarily signed informed consent.
- Adequate organ and bone marrow function, meeting the following definitions:
- Blood routine (no blood transfusion, no granulocyte colony stimulating factor [G-CSF], no other drug correction within 14 days before treatment);Absolute count of neutrophils (ANC) ≥1.5×109/L;Hemoglobin (HB) ≥9.0 g/dL;Platelet count (PLT) ≥80×109/L;
- Blood biochemistry, serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL/min;Serum albumin ≥2.8g/dL, for patients with poor nutritional status before neoadjuvant therapy, patients who met the requirements through parenteral nutrition could also be included in the group;Total bilirubin (TBIL) ≤ 1.5×ULN;Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN;
Who cannot join
- 1. Pregnant or lactating women;
- Patients with a known history of allergy to any investigative drug, similar drug or excipient;
- Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;
- Patients with a history of thromboembolism, except thrombosis caused by PICC;
- There are patients with active infection;
- Patients with unmanageable hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90mmHg);
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- Patients with brain metastases with clinical symptoms or imaging evidence;
- Contraindications exist in treatment with other chronic diseases;
- Patients with a history of immunotherapy-related myocarditis, pneumonia, colitis, hepatitis, nephritis, etc., with current AE ≥ grade 2;
- According to the evaluation criteria of NCI CTCAE version 5.0, there are patients with all kinds of toxicities ≥ grade 2 due to previous treatment;
- Other conditions that the researchers determined were not suitable for inclusion in the study.
- Received any antitumor therapy and participated in other clinical studies within 4 weeks before enrollment.
About this study
Official title: Efficacy and Safety of SBRT Followed by Tislelizumab Plus Cetuximab and Irinotecan in Patients With Previously Treated RAS Wild-type Advanced Refractory Colorectal Cancer: a Phase II, Single-arm Study
To evaluate the efficacy and safety of SBRT followed by tislelizumab plus cetuximab and irinotecan in patients with previously treated RAS wild-type advanced refractory colorectal cancer
- Conditions
- Colorectal Cancer
- Being tested
- Tislelizumab, Irinotecan Hydrochloride, cetuximab, SBRT
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.
Irinotecan will be administered on day 1 of each cycle at 180 mg/m2 once every 14 days.
cetuximabDrug
cetuximab will be administered on day 1 of each cycle at 500 mg/m2 once every 14 days.
SBRTRadiation
8-10Gy×5F，QOD
| Study group | Role | What they receive |
|---|---|---|
| SBRT followed by tislelizumab plus cetuximab and irinotecan | Experimental | Not described Receives: Drug: Tislelizumab; Drug: Irinotecan Hydrochloride; Drug: cetuximab; Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate(ORR)
ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR
Measured: From enrollment to 12 month
Secondary outcomes (2)
Progression-Free Survival(PFS)
PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first
Measured: From enrollment to 12 month
Overall Survival (OS)
Overall Survival (OS), defined as the time from the date of randomization to the date of death, regardless of the cause of death.
Measured: From enrollment to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start5 Apr 2023 (estimated)
- Primary completion5 Apr 2024 (estimated)
- Study completion5 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799443
- Sponsor's protocol ID
- STEC
- Status last verified
- Mar 2023
- First submitted
- 23 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of SBRT Followed by Tislelizumab Plus Cetuximab and Irinotecan in Patients With Previously Treated RAS Wild-type Advanced Refractory Colorectal Cancer: a Phase II, Single-arm Study
- ClinicalTrials.gov ID
- NCT05799443
- Acronym / sponsor ID
- STEC
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 5 Apr 2023 (estimated)
- Primary completion
- 5 Apr 2024 (estimated)
- Study completion
- 5 Apr 2025 (estimated)
- First posted
- 5 Apr 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.
To evaluate the efficacy and safety of SBRT followed by tislelizumab plus cetuximab and irinotecan in patients with previously treated RAS wild-type advanced refractory colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT followed by tislelizumab plus cetuximab and irinotecan | Experimental | Drug: Tislelizumab, Drug: Irinotecan Hydrochloride, Drug: cetuximab, Radiation: SBRT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18-75 years
- Physical Condition Score (ECOG PS) of the Eastern Cancer Cooperative Group (USA) 0 or 1;
- Colorectal cancer diagnosed histologically and/or cytologically has metastases or relapses that are not curable by surgery
- Have received first - and second-line systemic antitumor therapy for mCRC (chemotherapy drugs may include fluorouracil, oxaliplatin, irinotecan, e.g. XELOX, FOLFOX, FOLFIRI, FOLFOXIRI, XELIRI; Can be combined with or without targeted drugs, such as cetuximab, bevacizumab);And disease progression after second-line treatment;
- Evaluation of lung or liver metastases can be evaluated, with stereotactic radiotherapy maneuverability;
Key exclusion criteria (12 listed)
- 1. Pregnant or lactating women;
- Patients with a known history of allergy to any investigative drug, similar drug or excipient;
- Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;
- Patients with a history of thromboembolism, except thrombosis caused by PICC;
- There are patients with active infection;
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 |
|---|---|---|
| TislelizumabTislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days. | Drug | SBRT followed by tislelizumab plus cetuximab and irinotecan |
| Irinotecan HydrochlorideIrinotecan will be administered on day 1 of each cycle at 180 mg/m2 once every 14 days. | Drug | SBRT followed by tislelizumab plus cetuximab and irinotecan |
| cetuximabcetuximab will be administered on day 1 of each cycle at 500 mg/m2 once every 14 days. | Drug | SBRT followed by tislelizumab plus cetuximab and irinotecan |
| SBRT8-10Gy×5F，QOD | Radiation | SBRT followed by tislelizumab plus cetuximab and irinotecan |
Primary outcome
Objective response rate(ORR)
Time frame: From enrollment to 12 month
ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR
2 secondary outcomes
Progression-Free Survival(PFS)
Time frame: From enrollment to 12 month
Overall Survival (OS)
Time frame: From enrollment to 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, Irinotecan Hydrochloride and cetuximab in people with Colorectal Cancer, run by Fujian Cancer Hospital.
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 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 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate(ORR) (time frame: From enrollment to 12 month). 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 5 Apr 2023.