# Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC（AK104-IIT-13）

Source: https://onco.cc/trials/nct05794750/  
OnCo record `nct05794750` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by JIN JING, not yet recruiting.

## Summary

Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC（AK104-IIT-13） is a phase 2, interventional study registered as NCT05794750 by JIN JING, with a registry enrolment figure of 50 participants, started 2023-04-24 and due to reach its primary completion in 2027-04-24. Interventions recorded: AK104 injection; TME surgery; Capecitabine; Oxaliplatin. Conditions listed: Locally Advanced Rectal Cancer. Primary outcome: Pathologic complete response rate (pCR). Colorectal eligibility wording from the registry: "Fiber colonoscopy or diagnosis examination, the lower boundary of the lesion is 15m ≤ from the margin;". No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: planned
- Last checked: 2026-09-24
- Also known as: AK104-IIT-13
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: NCT05794750
- Phase: 2
- Setting: A Single-arm, Multicenter, Phase II Study Evaluating the Efficacy and Safety of Preoperative Short-course Radiotherapy Followed by Sequential Chemotherapy and AK104 for Locally Advanced Rectal Cancer
- Sponsor: JIN JING
- Enrolled: 50

## Sources

- ClinicalTrials.gov NCT05794750: https://clinicaltrials.gov/study/NCT05794750

## Connected records

- cancers: [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/), [Platinum agents](https://onco.cc/technologies/platinum/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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