SHR-1701 in Combination With Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer

Launched by SUZHOU SUNCADIA BIOPHARMACEUTICALS CO., LTD. · Mar 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SHR-1701, which is being tested alongside standard chemotherapy and radiotherapy for patients with locally advanced rectal cancer. The goal is to see how well this combination works and if it is safe for patients. Eligible participants are adults aged 18 and older who have been diagnosed with locally advanced rectal adenocarcinoma and whose tumors can be surgically removed. They should not have received previous treatments for their cancer and need to meet certain health requirements.

Participants in the trial will first receive chemoradiation along with SHR-1701, followed by surgery if their cancer is deemed resectable (can be removed). After surgery, they will continue to receive chemotherapy with SHR-1701. Throughout the trial, patients will undergo imaging tests to check the status of their cancer. This study is currently recruiting participants, and anyone considering joining should discuss their eligibility and any concerns with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Be willing and able to provide written informed consent for the trial.
• • 2. Locally advanced rectal adenocarcinoma and was evaluated as resectable ;
• • 3. The inferior margin of the tumor ≤ 10 cm from the anal verge ;
• • 4. No prior anti-cancer treatment for rectal cancer;
• • 5. Estern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1;
• • 6. Adequate hematologic and end-organ function;
• • 7. Contraception was initiated from the signing of the informed consent until at least 6 months after the last dosing of the study drug
• Exclusion Criteria:
• • 1. Unresectable disease determined by investigators
• • 2. Recurrent rectal cancer
• • 3. Evidence of metastatic disease or lateral lymph node metastases
• • 4. Presence of synchronous colorectal cancer
• • 5. Presence of obstruction or imminent obstruction
• • 6. Not eligible for long-course radiotherapy
• • 7. Severe cardiovascular and cerebrovascular diseases;Have clinical heart symptoms or diseases that are not well controlled
• • 8. Prior malignancy within the prior 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical/breast cancer.