Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer

NCT ID: NCT06024356

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-20
• Study Completion Date: 2024-03-30

Brief Summary

It is a single-center, retrospective, controlled study to investigate the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin for locally advanced mid-low rectal cancer.

Detailed Description

Study Purpose

1. To evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin for locally advanced mid-low rectal cancer.

2. To explore the effects of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin on the immune microenvironment of locally advanced mid-low rectal cancer.

Study Design: A single-center, retrospective, controlled study Subjects were divided into two groups according to whether or not they received thymalfasin: group 1 was treated with neoadjuvant chemoradiotherapy combined with PD-1 inhibitor, and group 2 was treated with neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin.

Subjects received long course radiotherapy (50 Gy/25f, 2 Gy/f, 5 days/week) for the first 5 weeks and three 21-day cycles capecitabine (1000 mg/m2, bid, po, day1-14) plus three 21-day cycles tislelizumab (200 mg, iv.gtt, day 8) for the first 9 weeks. After that, patients rested for two weeks (week 10-11)。6-8 weeks after the end of radiotherapy, patients underwent TME surgery (12-14 weeks). Thymalfasin was started on the first day of neoadjuvant chemoradiotherapy, 1.6 mg subcutaneously twice a week until the end of the last neoadjuvant treatment.

Enrollment: 26 participants, 13 in each group Study Population: locally advanced mid-low rectal cancer Primary Endpoint: pathologic complete response（pCR） Exploratory endpoint: Paraffin specimens were collected from biopsies before neoadjuvant therapy and after surgery in patients meeting the inclusion criteria. The expression of CD86, CD163, CD4+T，CD8+T，PD-1 were detected.

Conditions

Colorectal Neoplasms

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Experimental

long course radiotherapy (50 Gy/25f, 2 Gy/f, 5 days/week) for the first 5 weeks and three 21-day cycles capecitabine (1000 mg/m2, bid, po, day1-14) plus three 21-day cycles tislelizumab (200 mg, iv.gtt, day 8) for the first 9 weeks. After that, patients rested for two weeks (week 10-11)。6-8 weeks after the end of radiotherapy, patients underwent TME surgery (12-14 weeks). Thymalfasin was started on the first day of neoadjuvant chemoradiotherapy, 1.6 mg subcutaneously twice a week until the end of the last neoadjuvant treatment.

Thymalfasin

Intervention Type: DRUG

Thymalfasin (thymosin-alpha 1) is an immunomodulating agent able to enhance the Thl immune response. It has been evaluated for its immunomodulatory activities and related therapeutic potential in several diseases.

Control

long course radiotherapy (50 Gy/25f, 2 Gy/f, 5 days/week) for the first 5 weeks and three 21-day cycles capecitabine (1000 mg/m2, bid, po, day1-14) plus three 21-day cycles tislelizumab (200 mg, iv.gtt, day 8) for the first 9 weeks. After that, patients rested for two weeks (week 10-11)。6-8 weeks after the end of radiotherapy, patients underwent TME surgery (12-14 weeks).

No interventions assigned to this group

Interventions

Thymalfasin

Thymalfasin (thymosin-alpha 1) is an immunomodulating agent able to enhance the Thl immune response. It has been evaluated for its immunomodulatory activities and related therapeutic potential in several diseases.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with rectal adenocarcinoma must satisfied all the following conditions:

1. Stage II/III LARC (cT1-4aN0-2M0);

2. Tumor distal location≤10 cm from anal verge (MRI diagnosed);

• Patients regardless of gender with aged≥18 years
• ECOG score of 0 or 1
• Physical and viscera function of patients can withstand major abdominal surgery

Exclusion Criteria

• Current or previous active malignancy other than rectal cancer；
• Patients underwent major surgery within 4 weeks prior to neoadjuvant therapy；
• Patients have any condition affects the absorption of capecitabine through gastrointestinal tract；
• Patients have severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
• Patients with severe concomitant diseases with estimated survival≤5 years；
• Patients with present or previous moderate or severe liver and kidney damage；
• Patients preparing for or previously received organ or bone marrow transplant；
• Patients who have received immunosuppressive or systemic hormone therapy within 1 month prior to the start of neoadjuvant therapy；
• Patients with congenital or acquired immune deficiency (such as HIV infection)；
• Pregnant or lactating women.

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

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhongtao Zhang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Friendship Hospital, Capital medical University

Beijing, Xicheng Dis, China

Countries

China

Other Identifiers

BFH-TTNCRT

Identifier Type: -

Identifier Source: org_study_id