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

NCT ID: NCT04833387

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD-1 antibody + capecitabine + radiation

Group Type: EXPERIMENTAL

PD-1 antibody

Intervention Type: 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)

Interventions

PD-1 antibody

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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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;
• Have not received biological treatment in the past;
• Past endocrine therapy: unlimited.

Exclusion Criteria

• 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;
• Any unstable conditions or situations that may endanger patient safety and compliance

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Pei-Rong Ding

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

651 Dongfeng Road East

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40652024 (View on PubMed)

Other Identifiers

B2019-092

Identifier Type: -

Identifier Source: org_study_id