SHR-1701 in Combination With Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-1701；Capecitabine；Oxaliplatin.
- Who it may be relevant to
- Registry conditions: Locally Advanced Rectal Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug SHR-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
Primary outcome measures
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 [Time frame: At week 16, DAY1]
- Percentage of participants with Pathological complete response ( pCR ) [Time frame: At week 16, DAY1]
Secondary outcome measures (6)
- Tumor regression grade ( TRG ) [Time frame: At week 16, DAY1]
- Percentage of participants with R0 Resection ( R0 ) [Time frame: At week 16, DAY1]
- Percentage of participants with Clinical complete response ( cCR ) rate. [Time frame: At week 16, DAY1]
- Event-free survival ( EFS ) [Time frame: Year 1, Year 2, Year 3]
- Overall survival ( OS ) [Time frame: Year 1, Year 2, Year 3]
- Disease-free survival ( DFS ) [Time frame: Year 1, Year 2, Year 3]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Zhongshan Hospital — Shanghai
Publications
- Tang W, Lv Y, Xie H, Wei Y, Wang J, Yu M, Jiang Y, Mao R, Huang C, Rao S, Ding K, Chang W, He G, Xu J. Efficacy and safety of SHR-1701 combined with chemoradiotherapy as neoadjuvant treatment for locally advanced rectal cancer. Cancer Lett. 2026 Jan 1;636:218006. doi: 10.1016/j.canlet.2025.218006. Epub 2025 Aug 26. PMID 40876501
Identifiers
NCT: NCT05300269 · SHR-1701-II-213