A Phase 3 interventional study of Tislelizumab and Adjuvant chemotherapy in Colorectal Cancer and Microsatellite Instability High, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
Among 27 studies testing tislelizumab in Colorectal Neoplasms — 15 open to participants now, 19 under way, 1 of them phase 3. tislelizumab · Colorectal Neoplasms.
Among the 27 studies testing tislelizumab in Colorectal Neoplasms, this one has the largest planned enrollment, is one of 4 that started in 2024, is the only one in phase 3, reaches primary completion later than 13 of the 18 other live ones, and was the 20th registered.
6,544 studies on the registry are indexed under Colorectal Neoplasms; 1,666 are open to participants now.
Browse Colorectal Neoplasms studies →15 of the 27 studies testing tislelizumab in Colorectal Neoplasms are open now, in 5 countries. Recruiting first, the newest first:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Sites in Germany
Ages 18+
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Sites in Austria, Germany
Ages 18+
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Sites in China
Ages 18–80
Memorial Sloan Kettering Cancer Center · Sites in United States, Nigeria
Ages 18+
Sun Yat-sen University · Sites in China
Ages 18+
By country, each count listing its studies:
tislelizumab: first FDA approval 2024 (TEVIMBRA), first EMA approval 2023. What it is approved for, and how studies give it, is on its page →
Of the 1,184 Colorectal Neoplasms studies recruiting now, 767 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 124 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
27 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 24 · Phase 3 1
First in 2021; this study’s year is marked. 4 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 180 is above the median of 76 across 4,801 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 33 across the 27 interventional studies. Of the 2 that completed or were terminated, 2 (100%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 27 have an industry lead sponsor. The 10 most frequent:
Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 618 are open to participants now.
95 studies in Colorectal Neoplasms by Sun Yat-sen University: 48 open now, 58 under way, 11 of them phase 3. Of 14 finished, 0 (0%) have results posted.
Among the 95 studies in Colorectal Neoplasms by Sun Yat-sen University, this one is the 24th largest by planned enrollment of the 78 interventional ones that give a count, is one of 8 that started in 2024, is one of 17 in phase 3, reaches primary completion later than 43 of the 57 other live ones, and was the 71st registered.
Sun Yat-sen University’s Colorectal Neoplasms studies by the year they started, since 2005.
4 of the studies testing tislelizumab in Colorectal Neoplasms that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06520683Phase 3Sun Yat-sen UniversityAdjuvant PD-1 Blockade for High-risk Stage-II DMMR/MSI-H Colorectal Cancer | 2027-11-01 |
| NCT06356597Jing-yuan Fang, MD, Ph. DTislelizumab With Fruquintinib, Metronidazole, in Mismatch Repair-proficient or Microsatellite Stability, Advanced Colorectal Cancer: a Multicenter, Single Arm, Clinical Trial | 2026-12-30 |
| NCT07025850Fudan UniversityEfficacy Study of Digoxin Combined With Serplulimab and Chemotherapy in First-Line Treatment of MSS Advanced Colorectal Cancer | 2027-01-01 |
| NCT07453875Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityLDRT Sequential NIPS Immunochemotherapy for Peritoneal Metastasis of Gastric and Colorectal Cancer | 2027-11-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 27 studies testing tislelizumab in Colorectal Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Sun Yat-sen University’s 95 in Colorectal Neoplasms:
This tab as a report to print or save as PDF → With an account.
This open-label phase III trial investigates the efficacy of two cycles of PD-1 blockade (Tislelizumab) as adjuvant therapy to see how it works compared with standard of care (SOC) in treating patients with stage II dMMR/MSI-H colorectal cancer.
The rational of giving PD-1 blockade as adjuvant therapy is based on the fact that tumor recurrence is extremely low among patients receiving neoadjuvant immunotherapy, which suggests that PD-1 blockade may likely improve patients' long-term survival.
As for the short course (two cycles), we have the following considerations: firstly, the NICHE-2 trial, which adopted a two-cycle regimen, reported no recurrences during follow-up, suggesting that short-course anti-PD-1 therapy may be sufficient to improve the survival of patients with localized dMMR/MSI-H colorectal cancer. Secondly, the potential benefits of PD-1 blockade should be balanced against its toxicities, because patients with stage-II dMMR colorectal cancer generally have a good prognosis. Two cycles of PD-1 blockade have been shown to have a good safety profile, with low incidence of grade 3-4 and immune-related adverse events.
This is an open-label, multi-centre, randomised, phase III trial comparing the combination of PD-1 blockade + SOC versus SOC alone as adjuvant therapy for patients with high-risk stage-II dMMR/MSI-H colorectal cancer.
Primary Objective: To determine whether the addition of Tislelizumab can significantly improve disease-free survival (DFS) compared to standard of care in patients with high-risk stage-II colorectal cancer.
Secondary objectives:
OUTLINE: Patients are randomized to 1 of 2 arms, stratified by cT4 status.
Arm 1 (experimental group): patients receive Tislelizumab 200mg intravenously on day 1, with or without adjuvant chemotherapy, and repeat the treatment on day 22. Patients undergo routine follow-up every 3 months for the first 3 years, and then every 6 months for the year 4-5.
Arm 2 (control group): patients receive standard of care (SOC), whether with surveillance alone, single-agent Capecitabine, or CapeOx/FOLFOX, at the discretion of the doctor in charge. Patients undergo routine follow-up every 3 months for the first 3 years, and then every 6 months for the year 4-5.
Statistics According to the statistical design, 180 patients (90 per arm) are to be randomized. The study is expected to take up to 36 months to complete accrual.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two cycles of Tislelizumab 200mg intravenously, on day 1 and day 22, with or without adjuvant chemotherapy
Drug: Tislelizumab · Drug: Adjuvant chemotherapy
Receiving standard of Care (either with adjuvant chemotherapy or surveillance alone).
Drug: Adjuvant chemotherapy
- Tislelizumab 200mg (day 1 and day 22), administered after surgery
Also known as: Tislelizumab (Tevimbra)
* Adjuvant therapy is not mandatory. * Optional adjuvant regimens include FOLFOX, CapeOX, 5-FU+LV, or Capecitabine.
Disease-free survival (DFS)
DFS (tumor-specific) is defined as time from randomization to tumor relapse or tumor-related death. DFS will be compared between treatment arms using the stratified log rank test at one-sided level 0.025. If zero DFS events are observed in a certain stratum at an interim analysis and unstratified log-rank is used, all subsequent analyses for DFS will use unstratified log-rank test.
Time frame: 3 years
Overall survival (OS)
OS is defined as time from randomization to death from any cause. Overall survival will be compared between treatment arms using the log-rank test.
Time frame: 5 years
Incidence of adverse events
Assessed by Common Terminology Criteria for Adverse Events version 4.0. The overall adverse event rates and the immune-related adverse event rates will be compared between treatment arms using Chi-square test or Fisher's exact test, as appropriate.
Time frame: up to 30 days after last treatment
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Nov 2027, 36 months after the start.
Of 106 non-industry phase 3 interventional studies under Colorectal Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 116. This study's planned 36 months is below that.
Counting every sponsor, half of 175 studies reached it within 50 months; a quarter within 35 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Tislelizumab