Colorectal NeoplasmsPhase 2NCT05143099
Phase II Study of Tislelizumab Combined With Cetuximab and Irinotecan in the Treatment of Recurrent, Refractory mCRC
A Phase 2 study testing TEC in people with Colorectal Neoplasms, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This is a single arm, open phase II study to evaluate the efficacy and safety of tislelizumab combined with cetuximab + irinotecan in the treatment of Ras wild-type recurrent and refractory colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- TEC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 28 Feb 2024
- 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；
- The ECOG PS score of the eastern United States cancer cooperation group was 0 or 1;
- Ras wild-type colorectal cancer diagnosed by histology and / or cytology has metastasis or recurrence that cannot be cured by surgery;
- Have received at least second-line systemic anti-tumor treatment for MCRC and failed, in which chemotherapy drugs can include fluorouracil, oxaliplatin and irinotecan, such as XELOX, FOLFOX, FOLFIRI, folfoxiri and xeliri; targeted drugs can be combined or not, such as cetuximab and bevacizumab;
- At least one measurable lesion defined according to RECIST version 1.1;
- Patients with fertility must be willing to take efficient contraceptive measures during the study period and ≥ 120 days after the last administration of tirelizumab; female patients have negative urine or serum pregnancy test results ≤ 7 days before the first administration of the study drug;
- Fully understand this study and voluntarily sign the informed consent form.
Who cannot join
- The following laboratory indicators belong to the exclusion criteria:
- Absolute neutrophil count (ANC) < 1.5 × 109 / L, or platelet count < 100 × 109 / L, or hemoglobin < 9g / dL or 90g / L or 5.6mmol/l; Blood transfusion or growth factor support within 2 weeks before enrollment are not allowed to meet the enrollment criteria;
- Serum total bilirubin > 1.5 times the upper limit of normal value (ULN); Patients with liver metastasis > 2.5 times ULN;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 times ULN, or ALT and / or ast > 5 times ULN in patients with liver metastasis;
- Serum creatinine > 1.5 times the upper limit of normal value (ULN), or creatinine clearance < 60ml / min (calculated according to Cockcroft Gault formula);
- Partial prothrombin time (APTT) or prothrombin time (PT) > 1.5 times ULN (subject to the normal value of clinical trial and Research Center);
Show all 39Show fewer
- Albumin < 30g / L;
- Clinically significant electrolyte abnormalities;
- Any previous histological or hematological ctDNA test showed mismatch repair gene deletion (dmmr), microsatellite instability (MSI-H) and BRAF mutant patients;
- Previous immunotherapy, including anti-PD-1, anti-PD-L1, anti-CTLA-4 or any cellular immunotherapy;
- Have a history of active autoimmune disease or autoimmune disease that may recur;
- Patients with any disease requiring systemic treatment with corticosteroids (the dose of prednisone or equivalent drug > 10 mg / day) or other immunosuppressive drugs within ≤ 14 days before the administration of the first study drug need not be excluded if they have used any of the following steroid treatment schemes at present or in the past:
- Adrenal replacement steroids (dose of prednisone or equivalent ≤ 10 mg / day);
- Local, ocular, intra-articular, intranasal or inhaled corticosteroids with very low systemic absorption;
- Short term (≤ 7 days) prophylactic use of corticosteroids (e.g. for the treatment of contrast medium allergy) or for the treatment of non autoimmune diseases (e.g. delayed type hypersensitivity caused by contact allergens);
- there are a history of interstitial lung disease, non infectious pneumonia, pulmonary fibrosis, acute lung disease, or poorly controlled systemic diseases (including but not limited to diabetes, hypertension, etc.).
- Clinically uncontrollable diarrhea;
- chronic or active infections require systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection. Patients with a history of active tuberculosis infection ≥ 1 year before screening should also be excluded, unless proof can be provided that appropriate treatment has been completed;
- Brain metastasis or leptomeningeal metastasis;
- Clinically significant pleural effusion, pericardial effusion or ascites need to be drained for many times within 2 weeks before the first administration of the study drug;
- There is a clinically detectable second primary malignant tumor at the time of enrollment, or there have been other malignant tumors in the past 5 years (except fully treated skin basal cell carcinoma or cervical carcinoma in situ);
- despite the use of standard care, patients with poor control of diabetes or poor electrolyte control are still in control.
- Known history of human immunodeficiency virus infection;
- Untreated patients with chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA higher than 500 IU / ml and patients with positive hepatitis C virus (HCV) RNA should be excluded. Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA < 500 IU / ml), and cured hepatitis C patients were all selected;
- Any major surgical operation ≤ 28 days before the administration of the first study drug;
- Previous allogeneic stem cell transplantation or organ transplantation;
- Uncontrollable hypertension, i.e. systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg after single drug treatment;
- At present, there are gastrointestinal diseases such as duodenal ulcer, ulcerative colitis and intestinal obstruction, or other conditions that may cause gastrointestinal bleeding or perforation determined by the researchers; Or those who have a history of intestinal perforation and intestinal fistula and are not cured after surgical treatment;
- Patients with a history of arterial thrombosis or deep venous thrombosis within 6 months before enrollment, or with evidence or history of bleeding tendency within 2 months before enrollment, regardless of severity;
- Stroke or transient ischemic attack occurred within 12 months before enrollment;
- Skin wound, operation site, wound site, severe mucosal ulcer or fracture are not fully healed;
- Acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Or patients with cardiac insufficiency of NYHA grade 2 or above;
- Severe hypersensitivity to other monoclonal antibodies, irinotecan and its excipients;
- Have received any systemic chemotherapy within 28 days before the first study drug, or received immunotherapy (such as interleukin, interferon, thymosin), hormone therapy, targeted therapy, or any research therapy within 14 days or 5 half lives before the first study drug, whichever is shorter;
- Received any Chinese herbal medicine or proprietary Chinese medicine for cancer control within 14 days before the first study drug;
- Patients whose toxic and side effects (due to previous anticancer treatment) have not returned to baseline or stable levels, unless it is not considered that such AE may pose safety risks (such as hair loss, neuropathy and specific laboratory abnormalities);
- Have received live vaccine within 4 weeks (including) before the first administration of the study drug; Seasonal influenza vaccines are usually inactivated, so they are allowed to be used; Intranasal vaccine belongs to live vaccine, so it is not allowed to be used;
- The investigator considers that the subject has any clinical or laboratory abnormalities or compliance problems and is not suitable to participate in this clinical study;
- Serious psychological or mental abnormalities;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Clinical Study on the Efficacy and Safety of Immune Checkpoint Inhibitor Combined With Cetuximab and Irinotecan in the Treatment of Recurrent, Refractory and Metastatic Colorectal Cancer
This is a single arm, open phase II study to evaluate the efficacy and safety of tislelizumab combined with cetuximab + irinotecan in the treatment of Ras wild-type recurrent and refractory colorectal cancer. This study will include Ras wild-type colorectal cancer that failed at least second-line treatment in the past, including chemotherapy (oxaliplatin, irinotecan, fluorouracil) with or without targeted drugs (cetuximab, bevacizumab). 33 patients were planned to be treated with tislelizumab combined with cetuximab + irinotecan every 2 weeks. The enrollment time is expected to be 12 months and the follow-up is 24 months.
- Conditions
- Colorectal Neoplasms
- Being tested
- TEC
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECDrug
tislelizumab（an anti-PD-1 monoclonal antibody）+cetuximab（monoclonal antibody against EGFR）+irinotecan
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | tislelizumab combined with cetuximab and irinotecan Receives: Drug: TEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
proportion of patients with complete and partial remission in the best efficacy
Measured: 24 months after the last subject participating in
Secondary outcomes (3)
Disease control rate (DCR)
the best efficacy is the proportion of patients with complete remission, partial remission and stable disease
Measured: 24 months after the last subject participating in
Progression free survival time (PFS）
time from the start of medication to the initial progression of the disease
Measured: 24 months after the last subject participating in
Overall survival (OS）
time from the start of medication to death
Measured: 36 months after the last subject participating in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Feb 2021
- Primary completion12 Dec 2022
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tianshu Liu, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143099
- Sponsor's protocol ID
- TEC
- Status last verified
- Mar 2023
- First submitted
- 22 Nov 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study on the Efficacy and Safety of Immune Checkpoint Inhibitor Combined With Cetuximab and Irinotecan in the Treatment of Recurrent, Refractory and Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05143099
- Acronym / sponsor ID
- TEC
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 3 Dec 2021 (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 is a single arm, open phase II study to evaluate the efficacy and safety of tislelizumab combined with cetuximab + irinotecan in the treatment of Ras wild-type recurrent and refractory colorectal cancer. This study will include Ras wild-type colorectal cancer that failed at least second-line treatment in the past, including chemotherapy (oxaliplatin, irinotecan, fluorouracil) with or without targeted drugs (cetuximab, bevacizumab). 33 patients were planned to be treated with tislelizumab combined with cetuximab + irinotecan every 2 weeks. The enrollment time is expected to be 12 months and the follow-up is 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TECtislelizumab combined with cetuximab and irinotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years；
- The ECOG PS score of the eastern United States cancer cooperation group was 0 or 1;
- Ras wild-type colorectal cancer diagnosed by histology and / or cytology has metastasis or recurrence that cannot be cured by surgery;
- Have received at least second-line systemic anti-tumor treatment for MCRC and failed, in which chemotherapy drugs can include fluorouracil, oxaliplatin and irinotecan, such as XELOX, FOLFOX, FOLFIRI, folfoxiri and xeliri; targeted drugs can be combined or not, such as cetuximab and bevacizumab;
- At least one measurable lesion defined according to RECIST version 1.1;
Key exclusion criteria (39 listed)
- The following laboratory indicators belong to the exclusion criteria:
- Any previous histological or hematological ctDNA test showed mismatch repair gene deletion (dmmr), microsatellite instability (MSI-H) and BRAF mutant patients;
- Previous immunotherapy, including anti-PD-1, anti-PD-L1, anti-CTLA-4 or any cellular immunotherapy;
- Have a history of active autoimmune disease or autoimmune disease that may recur;
- Patients with any disease requiring systemic treatment with corticosteroids (the dose of prednisone or equivalent drug > 10 mg / day) or other immunosuppressive drugs within ≤ 14 days before the administration of the first study drug need not be excluded if they have used any of the following steroid treatment schemes at present or in the past:
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 |
|---|---|---|
| TECtislelizumab（an anti-PD-1 monoclonal antibody）+cetuximab（monoclonal antibody against EGFR）+irinotecan | Drug | 1 |
Primary outcome
Objective response rate (ORR)
Time frame: 24 months after the last subject participating in
proportion of patients with complete and partial remission in the best efficacy
3 secondary outcomes
Disease control rate (DCR)
Time frame: 24 months after the last subject participating in
Progression free survival time (PFS）
Time frame: 24 months after the last subject participating in
Overall survival (OS）
Time frame: 36 months after the last subject participating in
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: Yes
Related trials for Colorectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
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 TEC in people with Colorectal Neoplasms, run by Shanghai Zhongshan Hospital 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 7 inclusion and 39 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 28 Mar 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?
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: 24 months after the last subject participating in). 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 28 Mar 2023.