Clinical trial · Observational
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer
Efficacy and Safety of Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer: a Single-center, Retrospective, Controlled Study
NCT06024356CI-TRIAL-00115240completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thymalfasin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Experimental 1, preoperative Tα1
- description
- 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.
- interventionNames
- Drug: Thymalfasin
- label
- Control, no Tα1
- description
- 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).
- label
- Experimental 2, postoperative Tα1
- description
- 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 after surgery, 1.6 mg subcutaneously twice a week
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.