Metastatic Colorectal Cancer，NEDPhase 2CAMCO2NCT05360277
Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer
A Phase 2 study testing Tislelizumab + Capecitabine in people with Metastatic Colorectal Cancer，NED, run by Yanhong Deng at 1 site in China.
Trial summary
Surgery with integrated treatment for metastatic colorectal cancer (mCRC) has created a new clinical setting known as mCRC with no evidence of disease (NED). However, these patients have a high risk of developing persistent cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Colorectal Cancer，NED
- What is being tested?
- Tislelizumab + Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2023to 30 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 20 years, < 80 years
- Written informed consent
- Histologically or cytologically confirmed CRC
- Surgery with integrated treatment for metastatic colorectal cancer (mCRC) and achieved a statute of no evidence of disease (NED), as determined by a multidisciplinary tumor board.
- cytoreduction surgery achieves CC0 (no visible residual tumor) if there is peritoneal metastasis
- No previous chemotherapy
Show all 9Show fewer
- Synchronous or metachronous metastatic disease: maximum of two distant organs or regions involved
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate hematologic and organ function
Who cannot join
- Presence of any other active cancer
- Presence of active infections requiring antibiotics
- History of active autoimmune disease requiring systemic treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Yanhong Deng, MD, 008613925106525, 13925106525@163.com
Yanhong Deng, MD
About this study
Official title: Maintenance Tislelizumab Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease
Surgery with integrated treatment for metastatic colorectal cancer (mCRC) has created a new clinical setting known as mCRC with no evidence of disease (NED). However, these patients have a high risk of developing persistent cancer. This study aimed to investigate the efficacy and safety of Tislelizumab combined with capecitabine as a maintenance treatment for patients with mCRC-NED.
Read the detailed description
This is a Phase 2, randomized, open-label, single-center study designed to compare the efficacy and safety of tislelizumab+ capecitabine versus best-supported care as a first-line maintenance treatment in participants with mCRC-NED.
Patients who underwent synchronously or staged removal of primary and metastatic lesions, achieving NED, and histologically confirmed colorectal adenocarcinoma were recruited in this trial. The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and adverse events. This study will provide novel data on the efficacy and safety profile of the combination of tislelizumab and capecitabine in patients with mCRC-NED.
- Conditions
- Metastatic Colorectal Cancer，NED
- Being tested
- Tislelizumab + Capecitabine, Best supportive care
- Keywords
- Metastatic Colorectal Cancer，NED
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab + CapecitabineDrug
Tislelizumab 200mg iv every 3 weeks, for 1 year after completion of perioperative chemotherapy.
Capecitabine was given at a dose of 850 mg/m2 twice a day by mouth, 2 weeks on/ 1 week off, for 1 year after completion of perioperative chemotherapy.
Best supportive careOther
Best supportive care
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab + Capecitabine | Experimental | Tislelizumab 200mg every 3 weeks, or 1 year after completion of perioperative chemotherapy.
Capecitabine was given at a dose of 850 mg/m2 twice a day by mouth, 2 weeks on/ 1 week off, for 1 year after completion of perioperative chemotherapy. Receives: Drug: Tislelizumab + Capecitabine |
| Best supportive care | Active comparator | Best supportive care was the standard care in this setting. Receives: Other: Best supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
The time from NED to the first occurrence of any of the following events: local relapse, distant metastasis, or death from any cause.
Measured: 36 months
Secondary outcomes (2)
Overall survival
The time from NED to death from any cause
Measured: 60 months
Adverse events
Side effect of both agents
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start22 Aug 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer，NEDStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanhong Deng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanhong Deng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360277
- Sponsor's protocol ID
- CSWOG-C02
- Other IDs
- GIHSYSU-24
- Acronym
- CAMCO2
- Status last verified
- Dec 2023
- First submitted
- 30 Apr 2022
- Last updated
- 12 Dec 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 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Tislelizumab Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease
- ClinicalTrials.gov ID
- NCT05360277
- Acronym / sponsor ID
- CAMCO2 / CSWOG-C02
- Conditions
- Metastatic Colorectal Cancer，NED
- Keywords
- Metastatic Colorectal Cancer，NED
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Yanhong DengUniversity, hospital or other
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 4 May 2022 (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.
Surgery with integrated treatment for metastatic colorectal cancer (mCRC) has created a new clinical setting known as mCRC with no evidence of disease (NED). However, these patients have a high risk of developing persistent cancer. This study aimed to investigate the efficacy and safety of Tislelizumab combined with capecitabine as a maintenance treatment for patients with mCRC-NED.
Detailed description
This is a Phase 2, randomized, open-label, single-center study designed to compare the efficacy and safety of tislelizumab+ capecitabine versus best-supported care as a first-line maintenance treatment in participants with mCRC-NED.
Patients who underwent synchronously or staged removal of primary and metastatic lesions, achieving NED, and histologically confirmed colorectal adenocarcinoma were recruited in this trial. The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and adverse events. This study will provide novel data on the efficacy and safety profile of the combination of tislelizumab and capecitabine in patients with mCRC-NED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab + Capecitabine | Experimental | Drug: Tislelizumab + CapecitabineTislelizumab 200mg every 3 weeks, or 1 year after completion of perioperative chemotherapy. Capecitabine was given at a dose of 850 mg/m2 twice a day by mouth, 2 weeks on/ 1 week off, for 1 year after completion of perioperative chemotherapy. |
| Best supportive care | Active comparator | Other: Best supportive careBest supportive care was the standard care in this setting. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 20 years, < 80 years
- Written informed consent
- Histologically or cytologically confirmed CRC
- Surgery with integrated treatment for metastatic colorectal cancer (mCRC) and achieved a statute of no evidence of disease (NED), as determined by a multidisciplinary tumor board.
- cytoreduction surgery achieves CC0 (no visible residual tumor) if there is peritoneal metastasis
Key exclusion criteria (3 listed)
- Presence of any other active cancer
- Presence of active infections requiring antibiotics
- History of active autoimmune disease requiring systemic treatment
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 |
|---|---|---|
| Tislelizumab + CapecitabineTislelizumab 200mg iv every 3 weeks, for 1 year after completion of perioperative chemotherapy. Capecitabine was given at a dose of 850 mg/m2 twice a day by mouth, 2 weeks on/ 1 week off, for 1 year after completion of perioperative chemotherapy. | Drug | Tislelizumab + Capecitabine |
| Best supportive careBest supportive care | Other | Best supportive care |
Primary outcome
Disease-free survival
Time frame: 36 months
The time from NED to the first occurrence of any of the following events: local relapse, distant metastasis, or death from any cause.
2 secondary outcomes
Overall survival
Time frame: 60 months
Adverse events
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Metastatic Colorectal Cancer，NED
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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.
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 Tislelizumab + Capecitabine in people with Metastatic Colorectal Cancer，NED, run by Yanhong Deng 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 3 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: looking for participants now, as of the sponsor's last update on 12 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 36 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 12 Dec 2023.