Actively Recruiting
SCRT Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of MSS Locally Advanced Rectal Cancer
Led by Ruijin Hospital · Updated on 2025-08-28
55
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
C
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this phase 2 study is to learn about the efficacy and safety of short-course radiotherapy (SCRT) sequential Penpulimab in combination with CAPEOX in the neoadjuvant treatment of microsatellite stable (MSS) locally advanced rectal cancer. The main question it aims to answer is the role of immune checkpoint inhibitors in the neoadjuvant treatment of MSS rectal cancer. Participants will receive neoadjuvant treatment of SCRT sequential Penpulimab in combination with CAPEOX. Participants will undergo a clinical re-staging assessment at the end of neoadjuvant therapy to determine whether to adopt a watch-and-wait strategy or undergo radical surgery.
CONDITIONS
Official Title
SCRT Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of MSS Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age between 18 and 75 years
- ECOG performance status score of 0 or 1
- Pathologically confirmed rectal adenocarcinoma located in mid-low rectum (tumor lower border less than 10 cm from anal verge)
- Clinical stage II or III according to 8th Edition AJCC Cancer Staging Manual (cT1-2N1-2M0 or T3-4N0-2M0)
- No urgent surgery needed for complications like bleeding, perforation, or obstruction from rectal cancer
- Microsatellite stable (MSS) status confirmed by PCR capillary electrophoresis
- No previous anti-tumor treatment
- No distant metastasis
- Presence of measurable or clinically assessable tumor lesion
- Adequate organ and bone marrow function
- Women of childbearing potential and male partners of such women agree to use effective contraception during treatment and for 6 months after
You will not qualify if you...
- Recurrent rectal cancer
- Previous pelvic radiotherapy, rectal cancer surgery, chemotherapy, targeted therapy, or immune checkpoint inhibitors
- Unable to receive radiotherapy or allergy to Penpulimab, capecitabine, oxaliplatin, or their ingredients
- Intestinal obstruction caused by tumor unless patient has a stoma
- History of other primary cancers except those in complete remission for at least 2 years or adequately treated non-melanoma skin cancer or carcinoma in situ with no recurrence
- Active or recent (within 2 years) autoimmune disease, except certain stable conditions not requiring systemic treatment
- Major cardiovascular events or severe heart conditions within 6 months prior to treatment
- History of allogeneic organ or stem cell transplantation
- Uncontrolled infections including HIV
- Pregnant or breastfeeding women
- Participation in another drug clinical trial within 4 weeks
- Active hepatitis B or C infection
- Receipt of live attenuated vaccine within 4 weeks before or planned during study
- Major surgery within 4 weeks before enrollment
- History of interstitial pneumonia
- Other health conditions or lab abnormalities that increase risks or interfere with study participation as judged by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, None Selected, China, 200025
Actively Recruiting
Research Team
R
Ren Zhao, MD, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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