Trial · NCT07888309
SCRT + Fruquintinib + Tislelizumab + CAPOX Versus SCRT + Tislelizumab + CAPOX as Neoadjuvant Therapy for Locally Advanced Low Rectal Cancer
NCT07888309, Phase 2, Recruiting, Ruijin Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SCRT + Fruquintinib + Tislelizumab + CAPOX Versus SCRT + Tislelizumab + CAPOX as Neoadjuvant Therapy for Locally Advanced Low Rectal Cancer. Trials, record NCT07888309. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07888309
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SCRT + Fruquintinib + Tislelizumab + CAPOX Versus SCRT + Tislelizumab + CAPOX as Neoadjuvant Therapy for Locally Advanced Low Rectal Cancer
- NCT number
- NCT07888309
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Ruijin Hospital
- Conditions
- Rectal Neoplasms, Rectal Cancer, Adenocarcinoma
- Interventions
- Short-Course Radiotherapy, Fruquintinib, Tislelizumab, CAPOX
- First posted
- 2026-10-22
- Last updated
- 2026-10-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants achieving pathological complete response (pCR; ypT0N0) | At response restaging (rectal MRI, colonoscopy, and MRD) and surgical resection, approximately 11-12 weeks after enrollment | pCR is defined as the absence of any viable tumor cells in the primary tumor bed and regional lymph nodes (ypT0N0) in the surgical resection specimen, per AJCC 8th edition TNM and College of American Pathologists (CAP) protocols, determined by blinded central pathology review. Assessed on the total mesorectal excision (TME) specimen after completion of neoadjuvant therapy. Reported as the number and percentage of randomized participants achieving ypT0N0, with 95% confidence intervals (intention-to-treat). |
| Secondary | 3 years EFS | From enrollment to the time (3 years) | |
| Secondary | Overall Survival | From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months | Time from randomization to death from any cause, estimated by Kaplan-Meier method; reported as median OS with 95% confidence interval and the 5-year OS rate. |
| Secondary | R0 resection rate | From randomization to surgical resection (approximately 4-6 months) | |
| Secondary | Objective Response Rate | At restaging tumor assessment (rectal MRI) after completion of neoadjuvant therapy, approximately 11-12 weeks after enrollment, prior to surgery | |
| Secondary | Minimal Residual Disease (MRD) status | At restaging tumor assessment (rectal MRI) after completion of neoadjuvant therapy, approximately 11-12 weeks after enrollment, prior to surgery | |
| Secondary | Proportion of participants achieving organ preservation via Watch-and-Wait (W&W) without definitive surgery | Through study completion, assessed up to 24 months after enrollment | Among participants with clinical complete response (cCR; negative rectal MRI, colonoscopy, and MRD) at restaging approximately 11-12 weeks after enrollment, proportion who entered W\&W and avoided definitive total mesorectal excision/proctectomy through last follow-up. Reported as number and percentage with 95% confidence interval. Unit: proportion (%). |
| Secondary | Rate of local regrowth during Watch-and-Wait (W&W) surveillance | Through study completion, assessed up to 24 months after enrollment | Among participants managed by W\&W, proportion who develop local regrowth (detected by rectal MRI and/or colonoscopy with biopsy confirmation) during surveillance. Reported as number and percentage with 95% CI. Unit: proportion (%). |
| Secondary | Relapse-free survival (RFS) in Watch-and-Wait (W&W) participants | From date of randomization until local regrowth, distant metastasis, or death from any cause, whichever came first, assessed up to 36 months | Time from randomization to local regrowth, distant metastasis, or death from any cause, whichever came first, estimated by Kaplan-Meier; reported as median RFS with 95% CI. Unit: time (months). |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT07888309
GET https://conductscience.org/api/trials/v1/NCT07888309/registered