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NCT06239870: ESTIMATE
Single-arm, Single-center, Exploratory Phase II Clinical Study of Envafolimab Combined With Chemoradiotherapy in the Treatment of Locally Advanced pMMR/MSS Rectal Cancer
Phase 2 trial testing Envafolimab combined with chemoradiotherapy in the whole course of neoadjuvant therapy in Envafolimab Combined With Chemoradiotherapy in the Treatment of Locally Advanced pMMR/MSS Rectal Cancer in 35 participants. Status unknown.
30 September 2025
Quick facts
| Lead sponsor | Yunnan Cancer Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 1 April 2023 |
| Primary completion | 30 September 2025 |
| Estimated completion | 30 September 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Envafolimab combined with chemoradiotherapy in the whole course of neoadjuvant therapy — full drug profile →
Conditions studied
- Envafolimab Combined With Chemoradiotherapy in the Treatment of Locally Advanced pMMR/MSS Rectal Cancer — all drugs for Envafolimab Combined With Chemoradiotherapy in the Treatment of Locally Advanced pMMR/MSS Rectal Cancer →
Sponsor
Yunnan Cancer Hospital
Who can join
Adults 18 to 75, any sex, with Envafolimab Combined With Chemoradiotherapy in the Treatment of Locally Advanced pMMR/MSS Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Preoperative radiotherapy combined with 5-fluorouracil/capecitabine is currently the standard treatment for locally advanced rectal cancer. Although this strategy effectively reduces the risk of local recurrence, it fails to effectively improve the overall survival rate of patients . The root cause is that 5-fluorouracil/capecitabine based local radiotherapy is not effective in controlling potential micrometastases. Therefore, many studies try to combine preoperative radiotherapy with more intense chemotherapy and targeted drugs at the same time, as well as induction chemotherapy before preoperative radiotherapy and consolidation chemotherapy after, in order to obtain better efficacy. However, a number of studies have shown that increasing cytotoxic drugs fail to effectively improve pathologic complete response rate (pCR) and long-term survival rate, and significantly increase therapeutic toxicity . Therefore, the idea of trying to increase the efficacy of cytotoxic drugs by accumulating them does not work.Based on the use of PD-1/PD-L1 antibody in colorectal cancer and other solid tumors, and referring to the scheme of PD-1/PD-L1 antibody combined with radiotherapy in other solid tumors, we added envafolimab to local radiotherapy for advanced rectal cancer for exploration, with a view to further improving the pCR rate and long-term survival of patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06239870
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06239870 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Yunnan Cancer Hospital
- Last refreshed: 2 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06239870.
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