Trial · NCT07104604
Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined With Tislelizumab, Liposomal Irinotecan, and Capecitabine in the Treatment of pMMR Locally Advanced Rectal Adenocarcinoma With Low Rectal Involvement
NCT07104604, Phase 2, Recruiting, Affiliated Cancer Hospital of Shantou University Medical College
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined With Tislelizumab, Liposomal Irinotecan, and Capecitabine in the Treatment of pMMR Locally Advanced Rectal Adenocarcinoma With Low Rectal Involvement. Trials, record NCT07104604. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07104604
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined With Tislelizumab, Liposomal Irinotecan, and Capecitabine in the Treatment of pMMR Locally Advanced Rectal Adenocarcinoma With Low Rectal Involvement
- NCT number
- NCT07104604
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 51 participants, estimated
- Lead sponsor
- Affiliated Cancer Hospital of Shantou University Medical College
- Conditions
- Rectal Cancer
- Interventions
- Liposomal Irinotecan+Tislelizumab+Capecitabine+Rradiotherapy
- First posted
- 2025-08-05
- Last updated
- 2026-07-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete response (CR) rate | At surgery, or at the confirmatory organ-preservation assessment approximately 12-16 weeks after the start of neoadjuvant therapy. | The complete response (CR) rate is defined as the proportion of all evaluable participants who achieve either a pathological complete response (pCR) or a clinical complete response (cCR). A participant is classified as a responder if they achieve pCR (defined as no residual tumour on postoperative pathology, ypT0N0) for patients undergoing surgical resection, or confirmed cCR (defined as no clinical, endoscopic, or radiological evidence of residual tumour) for patients managed with organ preservation without resection. These two response categories are mutually exclusive, and the CR rate is calculated using a single shared denominator consisting of all evaluable participants. |
| Secondary | Major pathological response (MPR) rate | At surgery | The major pathological response (MPR) rate is defined as the proportion of resected participants with 10% or fewer residual viable tumour cells in the resection specimen (i.e., at least 90% of the tumour eliminated). |
| Secondary | Sphincter-preservation rate | At surgery | The proportion of resected participants who undergo sphincter-preserving surgery. |
| Secondary | R0 resection rate | At surgery | The proportion of resected participants achieving an R0 resection, defined as no tumour cells within 1 mm of the resection margin. |
| Secondary | Disease-free survival (DFS) | Up to 24 months | For resected participants, disease-free survival (DFS) is defined as the time from surgery to tumour recurrence or death from any cause; for watch-and-wait participants, DFS is defined as the time from the date of confirmed cCR to local regrowth, distant metastasis, or death from any cause (local regrowth is counted as a DFS event). A supportive analysis of DFS measured from the start of neoadjuvant therapy will also be reported to provide a common time origin across both treatment pathways. Participants without an event will be censored at the last tumour assessment. |
| Secondary | Local-regrowth-free survival and TME-free survival (watch-and-wait subgroup) | Up to 24 months | Among participants managed by organ preservation, two endpoints will be reported separately to distinguish salvageable local regrowth from oncological failure: local-regrowth-free survival (time from confirmed cCR to local regrowth) and TME-free survival (time from confirmed cCR to any total mesorectal excision, performed either for regrowth or by patient choice). |
| Secondary | Anorectal function (LARS score) | 3, 6, and 12 months after stoma reversal (resected) or after confirmed cCR (watch-and-wait) | Anorectal function assessed using the validated Low Anterior Resection Syndrome (LARS) score. |
| Secondary | Adverse events (safety and tolerability) | From first dose until 28 days after the last dose | Adverse events assessed systematically and graded according to NCI-CTCAE v5.0, including overall adverse-event rate, grade 3 or higher adverse-event rate, chemotherapy-related and immune-related adverse-event rates, and serious adverse-event rate. |
| Secondary | Treatment feasibility (regimen completion and dose intensity) | From first dose to completion of neoadjuvant therapy (approximately 12-16 weeks) | Feasibility of the four-modality neoadjuvant regimen, assessed by the proportion of participants completing the planned neoadjuvant treatment and by the relative dose intensity of each systemic agent (tislelizumab, liposomal irinotecan, and capecitabine) and of radiotherapy. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07104604
GET https://conductscience.org/api/trials/v1/NCT07104604/registered