NCT05300269 SHR-1701 in Combination With Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer
| NCT ID | NCT05300269 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | Locally Advanced Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 73 participants |
| Start Date | 2022-07-05 |
| Primary Completion | 2024-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 73 participants in total. It began in 2022-07-05 with a primary completion date of 2024-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05300269 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Locally Advanced Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05300269 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05300269 currently recruiting?
Yes, NCT05300269 is actively recruiting participants. Contact the research team at qing.yang@hengrui.com for enrollment information.
Where is the NCT05300269 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05300269 clinical trial?
NCT05300269 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 73 participants.
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