SCRT Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of MSS Locally Advanced Rectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Informed consent
18 years < age ≤ 75 years
ECOG score is 0-1
Patients with pathologically confirmed rectal adenocarcinoma, assessed by MRI as mid-low rectal cancer (the lower border of the tumor is less than 10cm from the anal verge), clinical stage II-III (cT1-2N1-2M0 or T3-4N0-2M0) according to the 8th Edition of AJCC Cancer Staging Manual
Disqualifiers
Recurrent rectal cancer
Previous treatment with pelvic radiotherapy, rectal cancer surgery, chemotherapy, targeted therapy, immune checkpoint inhibitors (including but not limited to PD-1, PD-L1, CTLA-4)
Proven inability to receive radiotherapy or allergy to the components of Penpulimab, capecitabine, oxaliplatin or their excipients
Intestinal obstruction due to tumor (except in patients who have received a stoma)
Trial design
Treatments tested in this trial
- Short-course radiotherapy
- Penpulimab
- CAPEOX
- TME surgery
Treatment groups
55 Participants
are divided into 1 treatment groupSponsors and collaborators
Ruijin Hospital
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborator
Source ClinicalTrials.gov