Colorectal cancer is a common gastrointestinal tumor, with rising incidence in China. Rectal cancer accounts for nearly half of new cases, and many patients are diagnosed at a locally advanced stage. Neoadjuvant chemoradiotherapy (nCRT) is the standard treatment, but only 20-30% achieve a complete response, with many experiencing recurrence or metastasis. Immunotherapy, particularly PD-1/PD-L1 inhibitors, has shown promise in improving outcomes, especially in dMMR/MSI-H patients. However, most rectal cancer patients have MSS, where combining immunotherapy with nCRT has shown moderate success in clinical trials. This project aims to explore the safety and efficacy of PD-1 inhibitor (pucotenlimab) combined with nCRT for locally advanced rectal cancer, potentially offering new treatment options.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Pucotenlimab combined with long-course concurrent chemoradiotherapy, followed by two cycles of pucotenlimab combined with chemotherapy, and then based on tumor response, TME surgery or a "watch and wait" strategy will be adopted.
Second Affiliated Hospital Of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGThe rate of cCR
The cCR assessment is defined by the fulfillment of the following three criteria: 1. Digital rectal examination of the original tumor area shows normal findings, with no palpable tumor masses. 2. Endoscopy reveals white, flat mucosal scars accompanied by surrounding capillary ectasia, without evidence of tumor ulcers or nodules; mucosal biopsy results are negative for cancer cells. 3. Contrast-enhanced MRI of the rectum shows: On T2-weighted images, only low signal intensity (dark on T2) is present without intermediate T2 signal intensity, and there are no signs of enlarged lymph nodes. there is no visible signal on diffusion-weighted (DW) images.
Time frame: From enrollment to the end of treatment at 12 weeks
The rate of pCR
The definition of pCR is that after surgery, in the pathological evaluation of the resected rectal cancer lesion, mesorectum, and regional lymph node samples, there are no visible tumor cells under the microscope. Tumor cells refer to viable tumor cells, excluding degenerated or necrotic cells. Pools of acellular mucin should not be assessed as residual tumor.
Time frame: From enrollment to the end of treatment at 16 weeks
The rate of TRG0
complete regression, defined as no residual tumor cells in the primary tumor and regional LNs (ypT0N0)
Time frame: From enrollment to the end of treatment at 16 weeks
The rate of R0 resection
R0 resection is defined as the removal of the rectal cancer lesion during surgery with no tumor cells present within 1 mm of the resection margins.
Time frame: From enrollment to the end of treatment at 16 weeks
Adverse events
The incidence, type, and severity of adverse events (AEs), serious AEs, and immune-related AEs (irAEs) were assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0).
Time frame: From enrollment to the end of treatment at 3 years
Surgical safety
Surgical safety was defined as the rate of surgical complications, including anastomotic leak, pelvic sepsis, and wound infection
Time frame: From enrollment to the end of treatment at 3 years
Event-Free Survival
Event-Free Survival (EFS) was defined as the period from the date of first treatment administration to the date of the first documented relevant event, where relevant events include disease progression that leads to inoperability, local recurrence or distant metastasis after surgery, and death due to any cause.
Time frame: From enrollment to the end of treatment at 3 years
Overall Survival
OS (Overall Survival) is defined as the period from the date of first treatment administration to the date of death due to any cause.
Time frame: From enrollment to the end of treatment at 3 years
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