PD-1 Antibody Following Preoperative Chemoradiotherapy for Locally Advanced pMMR/MSS Rectal Cancer

NCT04833387 | Active Not Recruiting Phase 2

• 1 other identifier: B2019-092
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In this open-label phase II study, patients will be scheduled for neoadjuvant treatment with PD-1 antibody following preoperative Chemoradiotherapy with capecitabine for pMMR/MSS rectal cancer staged as locally advanced (cT3-T4N+/-M0 for rectal cancer). This treatment will be given during the window period until surgical resection of the tumor.

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Pathological complete response

  Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging

  1 year

Secondary Outcomes (3)

• Relapse-free survival (RFS)

  3 years

• Overall survival (OS)

  3 years

• Clinical complete response (CCR)

  1 year

Study Arms (1)

PD-1 antibody + capecitabine + radiation

EXPERIMENTAL

Drug: PD-1 antibody

Interventions

PD-1 antibody DRUG

Capecitabine:Dose of 1650mg/m2,14days; Radiation:50Gy/25 fractions;IBI308: 200mg on day1 of each cycle, 3 cycles; Surgical therapy:The resection (LAR), intersphincteric resection (ISR), or abdominoperineal resection (APR)

PD-1 antibody + capecitabine + radiation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who personally provided written consent for participation in the study
• Treatment-naive patients with rectal cancer, in whom the inferior margin of the tumor was at a distance of 12 cm or less from the AV before CRT
• Primary rectal cancer histopathologically confirmed to be adenocarcinoma
• Clinical stage of T3,and T4 ,N any,M0,before CRT
• Macroscopic radical resection could be feasible, based on diagnostic imaging before CRT
• Patients with the ECOG performance status of 0 or 1 at the time of enrollment
• Patients without distant metastasis on the imaging test before CRT
• Preoperative biopsy of tumor immunohistochemistry TPS\>1% or CPS\>1
• Life expectancy of greater than 2 years
• No signs of intestinal obstruction; or the obstruction has been relieved after the proximal colostomy operation
• Hematology: WBC\>4000/mm3; PLT\>100000/mm3; Hb\>10g/dL
• Liver function: SGOT and SGPT are less than 1.5 times the normal value; bilirubin is less than 1.5mg/dL
• Renal function: creatinine \<1.8mg/dL Others: non-pregnant or breast-feeding women; no other malignant diseases (except for non-melanoma or cervical carcinoma in situ) within 5 years or during the same period; no mental illness that causes the inability to obtain informed consent; no other serious diseases that can shorten the survival time disease.
• Have not received rectal surgery in the past;
• Have not received chemotherapy or radiotherapy in the past;

You may not qualify if:

• Rectal cancer with unstable microsatellite (MSI or dMMR);
• Preoperative biopsy of tumor immunohistochemistry TPS≤1% or CPS≤1
• Known history of human immunodeficiency virus (HIV) or chronic hepatitis B or C (high copy viral DNA);
• Autoimmune diseases;
• Other active clinical serious infections (\>NCI-CTC version 3.0);
• Patients in clinical phase I;
• There is evidence that there is distant metastasis before surgery;
• Cachexia, decompensation of organ function;
• Have a history of pelvic or abdominal radiotherapy;
• Multiple primary cancers;
• Patients who need treatment for seizures (such as steroids or anti-epileptic treatment);
• Have a known additional malignant tumors within 5 years. Exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer;
• Chronic inflammatory bowel disease, intestinal obstruction;
• Drug abuse and medical, psychological or social conditions may interfere with patients' participation in research or have an impact on the evaluation of research results;
• Known or suspected to be allergic to the study drug or to any drug given in connection with this test;

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Liaoning Cancer Hospital & Institute: collaborator
• Fudan University: collaborator

Study Sites (1)

651 Dongfeng Road East

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Hou Z, Liao L, Xiao W, Sui Q, Han K, Xiao B, Li Y, Mei W, Yu J, Hong Z, Chen Q, Song R, Li D, Zhang X, Wang Q, Pan Z, Jiang W, Ding P. Neoadjuvant chemoradiotherapy plus sintilimab in pMMR/MSS rectal cancer patients with PD-L1 TPS >/= 1% or CPS >/= 1: an open-label, prospective, phase II study. NPJ Precis Oncol. 2025 Jul 12;9(1):237. doi: 10.1038/s41698-025-01018-0.

  PMID: 40652024 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

spartalizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: PD-1

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 6, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)