Trial · NCT07521605
Short-Course Radiotherapy, Nal-IRI, Capecitabine, and Camrelizumab for Locally Advanced MSS Rectal Cancer
NCT07521605, Phase 2, Not yet recruiting, Guangdong Provincial People's Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Short-Course Radiotherapy, Nal-IRI, Capecitabine, and Camrelizumab for Locally Advanced MSS Rectal Cancer. Trials, record NCT07521605. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07521605
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Short-Course Radiotherapy, Nal-IRI, Capecitabine, and Camrelizumab for Locally Advanced MSS Rectal Cancer
- NCT number
- NCT07521605
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 44 participants, estimated
- Lead sponsor
- Guangdong Provincial People's Hospital
- Conditions
- Rectal Cancer Patients
- Interventions
- Short-Course Radiotherapy, Liposomal Irinotecan (nal-IRI), Capecitabine, Camrelizumab
- First posted
- 2026-04-13
- Last updated
- 2026-04-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate | From the start of treatment until approximately 2 weeks after the completion of all neoadjuvant therapy, assessed over a period of approximately 24-26 weeks. | The primary endpoint is the Complete Response (CR) rate after completion of neoadjuvant therapy, which is a composite of pathological complete response (pCR) and clinical complete response (cCR). 1. pCR is defined as the absence of viable tumor cells in the surgical specimen (TRG1a according to the Becker tumor regression grading system) in patients who undergo surgery. 2. cCR is defined as the achievement of a ycT0N0 status, assessed by clinical evaluations (including digital rectal exam, endoscopy, MRI, etc.), in patients who enter a "Watch and Wait" strategy without immediate surgery. |
| Secondary | 3 year Disease-Free Survival | 3 years from the start of treatment. | Defined as the time from the start of treatment until disease recurrence, distant metastasis, or death from any cause, whichever occurs first. |
| Secondary | 3 year Overall Survival | 3 years from the start of treatment. | Defined as the time from the start of treatment until death from any cause. |
| Secondary | Objective Response Rate | From the start of treatment until approximately 2 weeks after the completion of all neoadjuvant therapy, assessed over a period of approximately 24-26 weeks. | Defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) as per RECIST 1.1 criteria. |
| Secondary | R0 Resection Rate | Assessed at the time of surgery following neoadjuvant therapy, over a period of approximately 24-30 weeks from the start of treatment. | Defined as the proportion of patients who undergo surgery and achieve a microscopically negative margin resection (R0 resection). |
| Secondary | Tumor Regression Grade | Assessed during pathological evaluation after surgery, over a period of approximately 24-30 weeks from the start of treatment. | Assessed on the surgical specimen using the Becker grading system: TRG 1a (complete response), TRG 1b (\<10% residual), TRG 2 (10%-50% residual), TRG 3 (\>50% residual). |
| Secondary | Sphincter Preservation Rate | Confirmed immediately after surgery, over a period of approximately 24-30 weeks from the start of treatment. | Defined as the proportion of patients undergoing radical surgery who successfully retain anal sphincter function (without a permanent colostomy). |
| Secondary | Incidence of Treatment-Related Adverse Events | From the time of informed consent until 30 days after the last dose of study treatment, assessed over a period of approximately 28-31 weeks. | The incidence and severity of treatment-related adverse events assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. |
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.
Papers23
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/NCT07521605
GET https://conductscience.org/api/trials/v1/NCT07521605/papers?page=2