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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

This study will evaluate the efficacy and safety of SHR-1701 combined with radiotherapy and chemotherapy as perioperative treatment for locally advanced rectal cancer. Eligible patients will receive standard chemoradiation with SHR-1701 followed by XELOX combined with SHR-1701. In all subjects, restaging pelvic MRI with chest and abdominal CT will be performed after completion of neoadjuvant treatment to determine resectability and to rule out any evidence of metastases. Subjects who have resectable disease will undergo surgery. Adjuvant XELOX combined with SHR-1701 will be given after surgery.

Eligibility criteria

Qualifiers

Be willing and able to provide written informed consent for the trial.

Locally advanced rectal adenocarcinoma and was evaluated as resectable ;

The inferior margin of the tumor ≤ 10 cm from the anal verge ;

No prior anti-cancer treatment for rectal cancer;

Disqualifiers

Unresectable disease determined by investigators

Recurrent rectal cancer

Evidence of metastatic disease or lateral lymph node metastases

Presence of synchronous colorectal cancer

Trial design

Treatments tested in this trial

  • SHR-1701;Capecitabine;Oxaliplatin

Treatment groups

73 Participants
are divided into 1 treatment group