A Phase 2 interventional study of SHR-1701 and SHR-8068 in Locally Advanced Colorectal Cancer, sponsored by Fudan University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
This is a prospective, open-label, single-center, phase II umbrella trial designed to evaluate the efficacy and safety of neoadjuvant therapy for locally advanced colorectal cancer. Patients will be stratified into four cohorts based on microsatellite instability (MSI) status, KRAS mutation status, and the consensus molecular subtypes (CMS). Six arms are included across four cohorts and each arm will be assigned to a specific treatment regimen. The primary endpoint is the complete response rate. Secondary endpoints include safety, organ preservation rate (for rectal cancer only), R0 resection rate, surgical complications, treatment compliance, 3-year survival, and quality of life (QoL) score.
Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: SHR-1701 · Drug: SHR-8068
Radiation: Short-course radiotherapy · Drug: XELOX (Capecitabine and Oxaliplatin) · Drug: PD-L1 antibody · Drug: HRS-7058
Radiation: Short-course radiotherapy · Drug: XELOX (Capecitabine and Oxaliplatin) · Drug: cetuximab β · Drug: HRS-7058
Radiation: Short-course radiotherapy · Drug: XELOX (Capecitabine and Oxaliplatin) · Drug: PD-L1 antibody · Drug: HRS-4642
Radiation: Short-course radiotherapy · Drug: XELOX (Capecitabine and Oxaliplatin) · Drug: cetuximab β · Drug: HRS-4642
Drug: SHR-1701 · Radiation: Short-course radiotherapy · Drug: XELOX (Capecitabine and Oxaliplatin)
1800mg d1 q3w
280mg，C1D1
25Gy/5Fx
Oxaliplatin: 130mg/m2 d1 q3w Capecitabine: 1000mg/m2 bid d1-14 q3w
1200mg d1 q3w
250mg/m2 d1, 500mg/m2 d8 q3w
200mg bid
500mg d1, 1200mg d8 q3w
Complete response (CR) rate: rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W&W strategy.
Time frame: 1 month after the surgery or 1 year after the decision of W&W.
Adverse effects rate: proportion of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0.
Time frame: From date of stratification to 3 months post-neoadjuvant therapy, an average of 8 months.
Organ preservation rate: proportion of participants who either achieve cCR and choose W&W or achieve cCR/near-cCR and choose local excision, out of the total participants who complete neoadjuvant therapy.
This endpoint is applicable only to patients with locally advanced rectal cancer.
Time frame: From date of stratification until the resection of rectum or anus, assessed up to 36 months.
R0 resection rate: proportion of surgical resections with negative margins (proximal, distal, and circumferential) on microscopic examination, with CRM negativity defined as > 1 mm from tumor bed.
Time frame: 1 month after the surgery.
Rate of surgical complications: rates of surgical complications such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.
Time frame: within 3 months after the surgery.
Treatment compliance: treatment completion rate and delay duration during the treatment period.
Time frame: From date of stratification to the completion of neoadjuvant therapy, an average of 5 months.
3 year local recurrence free survival rate: proportion of participants with no tumor recurrence in the primary site (e.g., rectum) or other pelvic regions within 3 years from date of surgery or cCR.
Time frame: From date of surgery or cCR until the date of first documented pelvic failure, assessed up to 36 months.
3 year distant metastasis free survival rate: proportion of participants with no distant metastases (e.g., liver, lung) within 3 years from date of stratification.
Time frame: From date of stratification until the date of first documented distant metastasis, assessed up to 36 months.
3 year disease free survival rate: proportion of participants with no disease recurrence (including local recurrence and distant metastasis) or death from the disease within 3 years from date of stratification.
Time frame: From date of stratification until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
3 year overall survival rate: proportion of participants who are alive at 3 years from date of stratification.
Time frame: From date of stratification until the date of death from any cause, assessed up to 36 months.
Quality of life (QoL) score: subjective assessment using validated standardized questionnaires.
Time frame: From date of stratification to 3 years post-neoadjuvant therapy.
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
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