Combining SHR-1701 with chemotherapy and radiotherapy for 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
This study is testing if adding SHR-1701 to standard chemotherapy and radiotherapy can help people with advanced rectal cancer have better treatment outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 73 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05300269 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of SHR-1701 when used alongside standard chemotherapy and radiotherapy for patients with locally advanced rectal cancer. Participants will receive standard chemoradiation treatment followed by a specific chemotherapy regimen (XELOX) combined with SHR-1701. After the neoadjuvant treatment, imaging tests will be conducted to assess the resectability of the cancer. Those with resectable tumors will undergo surgery, followed by additional chemotherapy with SHR-1701.
Who should consider this trial
Good fit: Ideal candidates are individuals with locally advanced rectal adenocarcinoma that is deemed resectable and who meet specific health criteria.
Not a fit: Patients with unresectable disease, recurrent rectal cancer, or evidence of metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with locally advanced rectal cancer.
How similar studies have performed: Other studies have shown promise in combining targeted therapies with standard treatments for various cancers, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Zhongshan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Qing Yang, M.D
- Email: qing.yang@hengrui.com
- Phone: +86 021-61053363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.