Clinical trial · Interventional
Envafolimab as Neoadjuvant Immuntherapy in Resectable Local Advanced dMMR/MSI-H Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Colorectal cancer (CRC) is one of the most common malignant tumours of human beings. Mismatch Repair-deficient (dMMR)/ Microsatellite Instability-high (MSI-H) CRC is a specific subtype of CRC, which accounts for approximately 15% of all CRC patients, and can not benefit from 5-fluorouracil (5-FU) adjuvant chemotherapy. Once patients have distant metastases, they are not sensitive to traditional palliative chemotherapy, and thus lead to much worse prognosis than that of mismatch repair-proficient (pMMR)/ microsatellite stability (MSS). A phase II clinical study of anti-PD-1 immunotherapy based on mismatch repair (MMR) status published in "N Engl J Med" showed that the objective response rate (ORR) of advanced colorectal cancer patients with dMMR received anti-PD-1 is 40%, and a longer response time can be obtained compared to conventional chemotherapy. Another study (ClinicalTrials.gov, NCT03926338) which investigating the effect of neoadjuvant PD-1 blockade with toripalimab, with or without celecoxib, on mismatch repair-deficient or microsatellite instability-high, locally advanced, colorectal cancer. The result revealed that all 34 patients had an R0 resection. 15 of 17 patients (88%) in the toripalimab plus celecoxib group and 11 of 17 patients (65%) in the toripalimab monotherapy group had a pathological complete response. In theory, anti-PD-L1 drugs should have fewer immune side-effects than anti-PD-1 drugs. However, there are no reports of anti-PD-L1 neoadjuvant therapy for the dMMR/MSI-H colorectal cancer. Therefore, the aim of this study was to investigate the efficacy and safety of anti-PD-L1 monoclonal antibody (Envafolimab) as neoadjuvant immuntherapy for resectable local advanced colorectal cancer patient with the dMMR/MSI-H.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Microsatellite Instability-high (MSI-H) | — | UNRESOLVED | — |
| Mismatch Repair-deficient (dMMR) | — | UNRESOLVED | — |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant therapy with PD-L1 inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD-L1 inhibitor
- description
- Neoadjuvant therapy with PD-L1 inhibitor (Envafolimab)
- interventionNames
- Drug: Neoadjuvant therapy with PD-L1 inhibitor
Primary outcomes (1)
- measure
- Pathological complete response (pCR) rates
- timeFrame
- 1 year
- description
- Proportion of patients experiencing a pCR to perioperative PD-L1 antibody
Secondary outcomes (6)
- measure
- Major pathological response rates
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Willing and able to provide written informed consent. 2. Histological or cytological documentation of adenocarcinoma of the colon or rectum. 3. Tumor tissues were identified as mismatch repair-deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR). 4. Male or female subjects \> 18 years \< 70 of age. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Determined CT or MRI scans (done within 14 days of registration) of the chest, abdomen and pelvis: locally advanced (cT3-4 or cN1-2 \[with the definition of a clinically positive lymph node being any node ≥ 1.0 cm\]). 7. Non complicated primary tumor (obstruction, perforation, bleeding). 8. No previous any systemic anticancer therapy for colorectal cancer disease or radiologic evaluation of tumor regression \< 20% or unacceptable toxic effects during neoadjuvant chemotherapy. 9. Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment. Exclusion Criteria: 1. Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization. 2. Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment. 3. Heart failure grade III/IV (NYHA-classification). 4. Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure. 5. Subjects with known allergy to the study drugs or to any of its excipients. 6. Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study. 7. Breast- feeding or pregnant women 8. Lack of effective contraception. 9. Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-lymphocyte-associated Protein 4, CTLA-4) antibody or other drug/antibody that acts on T cell costimulation or checkpoint pathways. 10. With any distant metastasis.
References
Publications (0)
Data not yet available