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

Colorectal Carcinoma Clinical Trial

Official title:

PD-1 Antibody as a Sequential Therapy Following Preoperative Chemoradiotherapy for Locally Advanced pMMR/MSS Rectal Cancer: an Open, Multi-center, Phase II Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04833387
• Other study ID #: B2019-092
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
China	651 Dongfeng Road East	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	Fudan University, Liaoning Tumor Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response	Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging	1 year
Secondary	Relapse-free survival (RFS)		3 years
Secondary	Overall survival (OS)		3 years
Secondary	Clinical complete response (CCR)		1 year