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A Study of Neoadjuvant QL1706 in Participants With Untreated dMMR/MSI-H Resectable Colon Cancer

RECRUITINGPhase 3Sponsored by Qilu Pharmaceutical Co., Ltd.
Actively Recruiting
PhasePhase 3
SponsorQilu Pharmaceutical Co., Ltd.
Started2024-12-12
Est. completion2030-12
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

Summary

The goal of this clinical trial is to evaluate the efficacy of neoadjuvant QL1706 in participants with untreated T4N0 or Stage III (resectable), microsatellite instability high/ defective mismatch repair (MSI-H/dMMR) colon cancer

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria:

* Signed written informed consent;
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Untreated pathologically confirmed colon adenocarcinoma
* Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only).
* Has a tumor demonstrating the presence of MSI-H/ dMMR
* Adequate organ function as described in the protocol

Exclusion Criteria:

* Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc
* Has distant metastatic disease.
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has know history of, or any evidence of interstitial lung disease;
* Has an active infection requiring systemic therapy

Conditions2

CancerColon Cancer

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