Colorectal NeoplasmsNCT06024356
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer
An observational study of Colorectal Neoplasms, run by Beijing Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Thymalfasin
- Type of treatment
- Injection or infusion
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2023to 15 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: locally advanced mid-low rectal cancer
Who may be able to join
- Patients with rectal adenocarcinoma must satisfied all the following conditions:
- Stage II/III LARC (cT1-4aN0-2M0);
- 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
Who cannot join
- 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；
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Friendship Hospital, Capital medical University
Beijing, Xicheng Dis, 100050
About this study
Official title: 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
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.
Read the detailed description
Study Purpose
- To evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin for locally advanced mid-low rectal cancer.
- 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: preoperative Tα1 (n=14), postoperative Tα1 (n=7), or no Tα1 (n=26) Study Population: locally advanced mid-low rectal cancer Primary Endpoint: 3-y DFS, pCR rate 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
- Being tested
- Thymalfasin
- Keywords
- Colorectal Neoplasms, Programmed Cell Death 1 Receptor, Thymalfasin, Neoadjuvant Therapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymalfasinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1, preoperative Tα1 | 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. Receives: Drug: Thymalfasin | |
| Control, no Tα1 | 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). | |
| Experimental 2, postoperative Tα1 | 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 Receives: Drug: Thymalfasin |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-y DFS
3-y DFS was defined as the time from surgery to disease recurrence, death, or last follow-up within 3 years
Measured: 3 years
pathologic complete response
All the enrolled patients will receive total mesorectal excision (TME) 7-9 weeks after the end of long course radiotherapy. The rectal specimens will be evaluated by the pathologists who are experienced on the rectal cancer diagnosis according to the 1997 Dworak grading system. The rectal cancer will be classified into 5 grades. Grade 0-3 will be considered as non-pCR while grade 4 represent pCR.
Measured: 1 year
Secondary outcomes (8)
neoadjuvant rectal (NAR) score
The neoadjuvant rectal (NAR) score is a promising indicator of survival after preoperative chemoradiotherapy for rectal cancer. The NAR score was calculated according to the following formula: NAR score = [5pN - 3(cT - pT) + 12]2⁄9.61.
(clinical tumor (cT) stage, pathologic tumor (pT) stage, pathologic nodal (pN) stage)
Measured: 1 year
tumor regression grade（TRG）
AJCC 8th TRG classification. TRG 0: No viable cancer cells left in the specimen; complete regression.
TRG 1: Minimal residual cancer cells present; extensive regression with a minimal number of tumor cells.
TRG 2: Moderate residual cancer cells present; substantial regression with a significant number of tumor cells.
TRG 3: Minimal or no regression; no significant tumor cell response to treatment; majority of tumor still present.
Measured: 1 year
objective response rate (ORR)
ORR is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The ORR rate is the sum of complete response (CR) and partial response (PR)
Measured: 1 year
R0 resection rate
During the surgical process, the surgeon will evaluate the level of cancer resection. It will be classified as R0, R1, R2 resection. Therefore, we can calculate R0 resection rate.
Measured: 1 year
anal preservation rate
the surgeon will decide whether the anal can be preserved on the basis of the rectal cancer and intraoperative situation. anal preservation rate is the percentage of patients who achieve anal preservation.
Measured: 1 year
disease free survival (DFS)
During the 3-year follow-up, the percentage of the patients who is disease free.
Measured: 3 year
local recurrence free survival
During the 3-year follow-up, the percentage of local recurrence.
Measured: 3 year
overall survival (OS)
During the 3-year follow-up, the percentage of the patients who is sill survival at the end of follow-up.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start20 Sep 2023
- Primary completion30 Apr 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024356
- Sponsor's protocol ID
- BFH-TTNCRT
- Status last verified
- Jun 2026
- First submitted
- 8 Aug 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06024356
- Acronym / sponsor ID
- BFH-TTNCRT
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal Neoplasms, Programmed Cell Death 1 Receptor, Thymalfasin, Neoadjuvant Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin for locally advanced mid-low rectal cancer.
- 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: preoperative Tα1 (n=14), postoperative Tα1 (n=7), or no Tα1 (n=26) Study Population: locally advanced mid-low rectal cancer Primary Endpoint: 3-y DFS, pCR rate 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental 1, preoperative Tα1 | – | Drug: Thymalfasinlong 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. |
| Control, no Tα1 | – | –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). |
| Experimental 2, postoperative Tα1 | – | Drug: Thymalfasinlong 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- locally advanced mid-low rectal cancer
Key inclusion criteria (6 listed)
- Patients with rectal adenocarcinoma must satisfied all the following conditions:
- 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
Key exclusion criteria (10 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThymalfasinThymalfasin (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. | Drug | Experimental 1, preoperative Tα1, Experimental 2, postoperative Tα1 |
Primary outcome
3-y DFS
Time frame: 3 years
3-y DFS was defined as the time from surgery to disease recurrence, death, or last follow-up within 3 years
pathologic complete response
Time frame: 1 year
All the enrolled patients will receive total mesorectal excision (TME) 7-9 weeks after the end of long course radiotherapy. The rectal specimens will be evaluated by the pathologists who are experienced on the rectal cancer diagnosis according to the 1997 Dworak grading system. The rectal cancer will be classified into 5 grades. Grade 0-3 will be considered as non-pCR while grade 4 represent pCR.
8 secondary outcomes
neoadjuvant rectal (NAR) score
Time frame: 1 year
tumor regression grade（TRG）
Time frame: 1 year
objective response rate (ORR)
Time frame: 1 year
R0 resection rate
Time frame: 1 year
anal preservation rate
Time frame: 1 year
disease free survival (DFS)
Time frame: 3 year
local recurrence free survival
Time frame: 3 year
overall survival (OS)
Time frame: 3 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-y DFS (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.