Colon CancerPhase 2NCT05833672
Neoadjuvant Immunotherapy in Locally Advanced Colon Cancers
A Phase 2 study testing Terelizumab and CapeOx in people with Colon Cancer and Immunotherapy, run by fan li at 1 site in China.
Trial summary
The aim of this study is to evaluate the safety and efficacy of neoadjuvant immunotherapy combined with chemotherapy before colonic resection in patients with locally advanced colon cancers Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer, Immunotherapy
- What is being tested?
- Terelizumab and CapeOx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients are able to understand and voluntarily sign the written informed consent, which must be signed prior to the implementation of the designated research procedures required by the study.
- The age at the time of signing the informed consent form (ICF) is ≥ 18 years old, both male and female.
- Locally advanced colonic adenocarcinoma (clinical stage T3-4N0M0 or T1-4N+M0 ) were diagnosed by comprehensive evaluation.
- The patients are willing to provide fresh tissue for biomarker analysis, and the tissue samples provided are of sufficient quality to evaluate the status of biomarkers. If sufficient tissue is not provided, repeated sampling may be required.
- The patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
- The expected survival time was ≥ 3 months.
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- The patient has adequate organs function. 1)The patient has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥1.5*10^9/L, hemoglobin ≥90g/L (5.58 mmol/L), and platelets ≥100*10^9/L.
- 2)The patient has adequate renal function as defined by a serum creatinine ≤1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥50 mL/minute (that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed).
- 3)The patient has adequate hepatic function as defined by a total bilirubin ≤1.5 mg/dL (25.65 μmol/L), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases).
- 4)The patient must have adequate coagulation function as defined by international normalized ratio (INR) ≤1.5 8.Within 7 days before the first administration, women of childbearing age must confirm that the serum pregnancy test is negative and agree to use effective contraceptives during the study period and within 180 days after the last administration. In this program, women of childbearing age are defined as sexually mature women:
- No hysterectomy or bilateral ovariectomy
- Natural menopause does not last for 24 months (amenorrhea after cancer treatment does not rule out fertility) (that is, menstruation occurs at any time in the previous 24 months).
- 9.For male patients whose sexual partners are women of childbearing age, they must agree to use effective contraception during the study drug use and within 180 days after the last administration.
Who cannot join
- Palliative local treatment was given to non-target lesions within 2 weeks before the first administration, and systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc.) was received within 2 weeks before the first administration. Chinese herbal medicine or proprietary Chinese medicine with anti-tumor indications was received within 2 weeks before the first administration.
- The patient has previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), immune cell therapy, etc. any treatment aimed at the immune mechanism of tumor.
- There was a history of gastrointestinal perforation and gastrointestinal fistula within 6 months before the first administration. If the perforation or fistula has been removed or repaired, and the disease has been judged by the researchers to recover or remission, it may be allowed to join the group.
- Active or previously recorded inflammatory bowel disease (such as Crohn's disease or ulcerative colitis). Unable to swallow, malabsorption syndrome, or uncontrollable nausea, vomiting, diarrhea or other gastrointestinal diseases that seriously affect drug use and absorption.
- There were active malignant tumors in the past 3 years, except for tumors that participated in the study and local tumors that had been cured. such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast cancer in situ, localized prostate cancer and so on.
- A history of allergy to study drug components or a history of severe hypersensitivity reaction to any monoclonal antibody.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Arm Study of Neoadjuvant Immunotherapy Combined With Chemotherapy in Locally Advanced Colon Cancers
The aim of this study is to evaluate the safety and efficacy of neoadjuvant immunotherapy combined with chemotherapy before colonic resection in patients with locally advanced colon cancers
Read the detailed description
The trial is designed as an investigator-initiated, single center, prospective, single arm phase II study in patients with locally advanced colon cancers scheduled for intended curative surgery to determine the efficacy of immunotherapy using tislelizumab in the neoadjuvant setting. Patients will receive CapeOX + Terelizumab therapy(Day 1 through Day 21) following diagnosis. After 3 weeks a re-evaluation (to assess tumor response) will be performed, followed by standard surgery for resection of the tumor. Surgery will therefore be performed within 3 to 5 weeks after 2 cycle of neoadjuvant combined immunotherapy.. The patients will be followed as per the standard Danish guidelines with CT scans at 1 and 3 years after surgery. The specimen collected by surgery and clinical data will be collected . We use Integrative omics analysis to establish a clinical efficacy prediction model by means of bioinformatics to prospectively judge the efficacy and guide the follow-up individualized and accurate treatment.
- Conditions
- Colon Cancer, Immunotherapy
- Being tested
- Terelizumab, CapeOx
- Keywords
- Immunotherapy, Colon Cancer, neoadjuvant, Terelizumab, Multi-omics analysis
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerelizumabDrug
q3w Terelizumab 200mg on day 1 of each cycle
CapeOxDrug
Oxaliplatin(130mg/m2) on day 1 of each cycle and Capecitabine:Dose of 1000mg/m2,14days
| Study group | Role | What they receive |
|---|---|---|
| Locally Advanced Colon Cancers | Experimental | Cycle 1 to Cycle 2 CapeOX + Terelizumab therapy(Day 1 through Day 21) Receives: Drug: Terelizumab; Drug: CapeOx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response
Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging
Measured: 6 months
ORR (objective response rate)
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
Measured: 6 months
Secondary outcomes (4)
Major pathologic response (MPR)
It is defined as residual tumors less than 10% after neoadjuvant immunotherapy and(or) chemotherapy
Measured: 6 months
Overall survival (OS)
Time from study entry to death from any cause.
Measured: 2 years
Disease-free survival (DFS)
Time from study entry to disease recurrence or patient death due to disease progression
Measured: 2 years
R0 resection rate
Rate of microscopically margin-negative resection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- fan li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, fan li, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833672
- Sponsor's protocol ID
- NICO-D
- Status last verified
- Apr 2023
- First submitted
- 16 Apr 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Study of Neoadjuvant Immunotherapy Combined With Chemotherapy in Locally Advanced Colon Cancers
- ClinicalTrials.gov ID
- NCT05833672
- Acronym / sponsor ID
- NICO-D
- Conditions
- Colon Cancer, Immunotherapy
- Keywords
- Immunotherapy, Colon Cancer, neoadjuvant, Terelizumab, Multi-omics analysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- fan liUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 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.
The aim of this study is to evaluate the safety and efficacy of neoadjuvant immunotherapy combined with chemotherapy before colonic resection in patients with locally advanced colon cancers
Detailed description
The trial is designed as an investigator-initiated, single center, prospective, single arm phase II study in patients with locally advanced colon cancers scheduled for intended curative surgery to determine the efficacy of immunotherapy using tislelizumab in the neoadjuvant setting. Patients will receive CapeOX + Terelizumab therapy(Day 1 through Day 21) following diagnosis. After 3 weeks a re-evaluation (to assess tumor response) will be performed, followed by standard surgery for resection of the tumor. Surgery will therefore be performed within 3 to 5 weeks after 2 cycle of neoadjuvant combined immunotherapy.. The patients will be followed as per the standard Danish guidelines with CT scans at 1 and 3 years after surgery. The specimen collected by surgery and clinical data will be collected . We use Integrative omics analysis to establish a clinical efficacy prediction model by means of bioinformatics to prospectively judge the efficacy and guide the follow-up individualized and accurate treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Locally Advanced Colon Cancers | Experimental | Drug: Terelizumab, Drug: CapeOxCycle 1 to Cycle 2 CapeOX + Terelizumab therapy(Day 1 through Day 21) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The patients are able to understand and voluntarily sign the written informed consent, which must be signed prior to the implementation of the designated research procedures required by the study.
- The age at the time of signing the informed consent form (ICF) is ≥ 18 years old, both male and female.
- Locally advanced colonic adenocarcinoma (clinical stage T3-4N0M0 or T1-4N+M0 ) were diagnosed by comprehensive evaluation.
- The patients are willing to provide fresh tissue for biomarker analysis, and the tissue samples provided are of sufficient quality to evaluate the status of biomarkers. If sufficient tissue is not provided, repeated sampling may be required.
- The patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
Key exclusion criteria (6 listed)
- Palliative local treatment was given to non-target lesions within 2 weeks before the first administration, and systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc.) was received within 2 weeks before the first administration. Chinese herbal medicine or proprietary Chinese medicine with anti-tumor indications was received within 2 weeks before the first administration.
- The patient has previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), immune cell therapy, etc. any treatment aimed at the immune mechanism of tumor.
- There was a history of gastrointestinal perforation and gastrointestinal fistula within 6 months before the first administration. If the perforation or fistula has been removed or repaired, and the disease has been judged by the researchers to recover or remission, it may be allowed to join the group.
- Active or previously recorded inflammatory bowel disease (such as Crohn's disease or ulcerative colitis). Unable to swallow, malabsorption syndrome, or uncontrollable nausea, vomiting, diarrhea or other gastrointestinal diseases that seriously affect drug use and absorption.
- There were active malignant tumors in the past 3 years, except for tumors that participated in the study and local tumors that had been cured. such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast cancer in situ, localized prostate cancer and so on.
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 |
|---|---|---|
| Terelizumabq3w Terelizumab 200mg on day 1 of each cycle | Drug | Locally Advanced Colon Cancers |
| CapeOxOxaliplatin(130mg/m2) on day 1 of each cycle and Capecitabine:Dose of 1000mg/m2,14days | Drug | Locally Advanced Colon Cancers |
Primary outcome
Pathological complete response
Time frame: 6 months
Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging
ORR (objective response rate)
Time frame: 6 months
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
4 secondary outcomes
Major pathologic response (MPR)
Time frame: 6 months
Overall survival (OS)
Time frame: 2 years
Disease-free survival (DFS)
Time frame: 2 years
R0 resection rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Terelizumab and CapeOx in people with Colon Cancer and Immunotherapy, run by fan li 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 13 inclusion and 6 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 27 Apr 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 L [fli] (86 023 68757958, levinecq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (time frame: 6 months). The study lists 2 primary outcomes in all. 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 27 Apr 2023.