Skip to content

Trial · Interventional

Active, not recruitingPhase 2Registry data

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

Overview

Status
Active, not recruiting
Phase
Phase 2
Enrollment
20 participants (estimated)
Sponsor
Beijing Friendship Hospital · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

China

Start
3 Jan 2024
Primary completion
1 Dec 2024
Completion
1 Jul 2027 (estimated)
First posted
28 Sept 2023
Last update posted
2 Apr 2025
Conditions
Locally Advanced Rectal Cancer

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20242025202620272028
  1. Ph 2

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

    NCT06056804

    3 Jan 2024 to est. 1 Jul 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is an open, prospective, multi-center, single-arm phase II clinical study assessing the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin in patients with pMMR/MSS locally advanced middle and low rectal cancer.

Interventions

  • capecitabineDrug
  • tislelizumabDrug
  • thymalfasinDrug
  • long-term radiotherapyRadiation

Arms1

  • Experimental

    cCRT+tislelizumab+thymalfasin

    A total of 20 pMMR/MSS locally advanced middle and low rectal cancer patients will receive long-course concurrent chemoradiotherapy combined with 3 cycles of tislelizumab and 11 weeks of thymalfasin therapy.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. CR rate

    Time frame · from preoperative to 10 days postoperative

    Registry description

    complete response rate, If patients achieved cCR after neoadjuvant therapy or were confirmed pCR after TME, they were considered as complete response (CR). pCR was defined as no residual tumor cells on the histologic examination of surgical specimens according to AJCC 8th edition. cCR was defined according to the Memorial Sloan Kettering Cancer Center (MSKCC) standard.

Secondary outcomes(7)
  1. TRAE

    Time frame · from commencing of treatment to the 30th day after surgery

    Registry description

    incidence of treatment-related adverse event

  2. 30-day incidence of postoperative complications

    Time frame · within 30 days after surgery

    Registry description

    incidence of surgical complications within 30 days after surgery

  3. ORR

    Time frame · before surgery

    Registry description

    objective response rate; The ORR rate is the result of complete response (CR) rate plus partial response (PR) rate.

  4. 3-y DFS rate

    Time frame · 3 years

    Registry description

    3-year disease free survival rate

  5. NAR score

    Time frame · within 10 days after surgery

    Registry description

    neoadjuvant rectal score

  6. R0 resection rate

    Time frame · within 10 days after surgery

    Registry description

    rate of R0 resection

  7. anal preservation rate

    Time frame · instantly after surgery

    Registry description

    proportion of patients with preserved anal sphincter

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Animal study · 2020

4 results

Thymosin α1 protects from CTLA-4 intestinal immunopathology.

Renga et al. 2020Life science alliancecited by 26

PMID 32817121PMC7441522DOI 10.26508/lsa.202000662PUB-32817121

CC BY4 results

PubMed tag: none · 2018

2 results

Long-term follow up of metastatic melanoma patients treated with Thymosin alpha-1: investigating immune checkpoints synergy.

Danielli et al. 2018Expert opinion on biological therapycited by 20

PMID 30063847DOI 10.1080/14712598.2018.1494717PUB-30063847

Full text at the publisher2 results

Indexing hint: Animal study · 2015

7 results

Evaluation of thymosin α 1 in nonclinical models of the immune-suppressing indications melanoma and sepsis.

King et al. 2015Expert opinion on biological therapycited by 18

PMID 25643200DOI 10.1517/14712598.2015.1008446PUB-25643200

Full text at the publisher7 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Patients who were fully informed of the study and voluntarily signed the informed consent form; 2. Patients with rectal cancers must satisfied all the following conditions: 1\) Stage II/III LARC (cT3-4aN0M0 and cT1-4aN1-2M0); 2) Tumor distal located ≤ 10 cm from anal verge (MRI diagnosed); 3) pMMR or MSS confirmed by immunohistochemistry or genetic test. 3.Patients regardless of gender with aged ≥18 years and ECOG score of 0 or 1; 4. Physical and viscera function of patients can withstand major abdominal surgery; 5.Patients are willing and able to follow the study protocol during the study 6.Patients give consent to the use of pathological specimens for study 7.Within 28 days prior to enrolment, we must confirm a negative serological pregnancy test for child-bearing age women and they agree to use effective contraception for the duration of drug use and for 60 days after the last dose. Exclusion Criteria: 1. Patients have a present or previous active malignancy except the diagnosis of rectal cancer this time; 2. Patients underwent major surgery within 4 weeks prior to study treatment; 3. Patients have any condition affects the absorption of capecitabine through gastrointestinal tract; 4. Patients have severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases; 5. Patients who are allergic to any of the ingredients under study; 6. Patients with severe concomitant diseases with estimated survival ≤ 5 years; 7. Patients with present or previous moderate or severe liver and kidney damage presently or previously; 8. Patients have received other study medications or any immunotherapy currently or in the past; 9. Patients preparing for or previously received organ or bone marrow transplant; 10. Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of study therapy; 11. Patients with congenital or acquired immune deficiency (such as HIV infection); 12. If patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the investigator will determine whether the clinical severity prevents the signing of informed consent or affects the patient's oral medication compliance; 13. Patients with other factors that may affect the study results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment and severe laboratory examination abnormalities. 14. Pregnant or lactating women Criteria for Withdrawal: 1. The subject withdraws informed consent; 2. The subject requests to withdraw from the study, or loses follow-up; 3. The subject demonstrates poor compliance and is unable to participate in the treatment and visits as required by the study protocol; 4. The subject experiences intolerable adverse events, and the investigator determines that continuing the study may be detrimental to the subject; 5. Other reasons, where the investigator determines it is not suitable for the subject to continue in the study. Criteria for Study Termination: 1. There are major errors in the study protocol; 2. The study involves significant risks and is terminated following review by the ethics committee; 3. Termination requested by the sponsor or regulatory authorities.

PepBank is a research reference. Talk to a doctor before you use any peptide.