drugset / Trial / NCT02605265
Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1
Phase 3
Completed
356 enrolled
Fudan University
First Affiliated Hospital of Chongqing Medical University · collabHubei Cancer Hospital · collabRuijin Hospital · collabThe First Affiliated Hospital with Nanjing Medical University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The study evaluate the addition of Irinotecan in neoadjuvant chemoradiation. Half of participants will receive capecitabine alone together with neoadjuvant CRT, followed by a cycle of XELOX, while the other will receive capecitabine and irinotecan during CRT, followed by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT, then 5 cycles of adjuvant chemotherapy of XELOX.
Timeline
- Start
- 2015-10
- Primary completion
- 2017-12
- Completion
- 2023-06
Outcome
Met primary endpoint
paper The pCR rates were 15% (n = 27 of 178) and 30% (n = 53 of 178) in the control and experimental groups PMID 33119477 ↗
paper risk ratio, 1.96; 95% CI, 1.30 to 2.97; P = .001 PMID 33119477 ↗
Publications
- Zhang Z, Sun X, Liu A, Zhu Y, Zhang T, Liu L, Jia J, Tan S, Wu J, Wang X, Zhou J, Yang J, Zhang C, Zhang H, He X, Cai G, Huang C, Xia F, Wan J, Zhang H, Shen L, Wang L, Zhang W, Cai S, Zhu J. Neoadjuvant chemoradiotherapy with capecitabine and irinotecan guided by UGT1A1 status in patients with locally advanced rectal cancer: 5-year update of the CinClare trial. Cancer Commun (Lond). 2025 Nov;45(11):1417-1430. doi: 10.1002/cac2.70058. Epub 2025 Sep 3.
- Zhang X, Fan J, Zhang L, Wang J, Wang M, Zhu J. Association Between Three-Dimensional Transrectal Ultrasound Findings and Tumor Response to Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer: An Observational Study. Front Oncol. 2021 Jun 4;11:648839. doi: 10.3389/fonc.2021.648839. eCollection 2021.
- Zhu J, Liu A, Sun X, Liu L, Zhu Y, Zhang T, Jia J, Tan S, Wu J, Wang X, Zhou J, Yang J, Zhang C, Zhang H, Zhao Y, Cai G, Zhang W, Xia F, Wan J, Zhang H, Shen L, Cai S, Zhang Z. Multicenter, Randomized, Phase III Trial of Neoadjuvant Chemoradiation With Capecitabine and Irinotecan Guided by UGT1A1 Status in Patients With Locally Advanced Rectal Cancer. J Clin Oncol. 2020 Dec 20;38(36):4231-4239. doi: 10.1200/JCO.20.01932. Epub 2020 Oct 29.
- Yao Y, Xu X, Yang L, Zhu J, Wan J, Shen L, Xia F, Fu G, Deng Y, Pan M, Guo Q, Gao X, Li Y, Rao X, Zhou Y, Liang L, Wang Y, Zhang J, Zhang H, Li G, Zhang L, Peng J, Cai S, Hu C, Gao J, Clevers H, Zhang Z, Hua G. Patient-Derived Organoids Predict Chemoradiation Responses of Locally Advanced Rectal Cancer. Cell Stem Cell. 2020 Jan 2;26(1):17-26.e6. doi: 10.1016/j.stem.2019.10.010. Epub 2019 Nov 21.
- Guan Y, Shen Y, Xu Y, Li C, Wang J, Gu W, Lian P, Huang D, Cai S, Zhang Z, Zhu J. An expansion study of genotype-driven weekly irinotecan and capecitabine in combination with neoadjuvant radiotherapy for locally advanced rectal cancer with UGT1A1 *1*1 genotype. Ther Adv Gastroenterol. 2019 Jun 6;12:1756284819852293. doi: 10.1177/1756284819852293. eCollection 2019.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 625 mg/m2 | — |
| Subject | Capecitabine | Small molecule | 825 mg/m2 | — |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 65 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 80 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 200 mg/m2 | — |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | — |
Indications
No indication recorded.