RecruitingPhase 2NCT05300269

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

SHR-1701 in Combination With Radiotherapy and Chemotherapy as Perioperative Treatment for Resectable Locally Advanced Rectal Cancer, an Open Label, Single-arm, Multicenter Phase II Trial

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

73 participants

Start Date

Jul 5, 2022

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Rectal Cancer

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

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;
Estern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1;
Adequate hematologic and end-organ function;
Contraception was initiated from the signing of the informed consent until at least 6 months after the last dosing of the study drug

Exclusion Criteria8

Unresectable disease determined by investigators
Recurrent rectal cancer
Evidence of metastatic disease or lateral lymph node metastases
Presence of synchronous colorectal cancer
Presence of obstruction or imminent obstruction
Not eligible for long-course radiotherapy
Severe cardiovascular and cerebrovascular diseases;Have clinical heart symptoms or diseases that are not well controlled
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.

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Interventions

DRUGSHR-1701；Capecitabine；Oxaliplatin

Radiation: Radiation therapy 50.4Gy in 28 fractions to the pelvis on Days 1-5 every week. Drug: Capecitabine Capecitabine 825mg/m\^2 orally twice daily (bid) 5 days/week during radiotherapy. Drug:SHR-1701 Drug: Capecitabine (XELOX) Capecitabine 1000mg/m\^2 orally twice daily (bid) day1-day14, q3w. Drug: Oxaliplatin Oxaliplatin 130mg/m\^2, day1, iv, q3w