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Locally Advanced Rectal CancerPhase 2NCT06056804

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

A Phase 2 study testing capecitabine, tislelizumab and thymalfasin in people with Locally Advanced Rectal Cancer, run by Beijing Friendship Hospital at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Locally Advanced Rectal Cancer
What is being tested?
capecitabine, tislelizumab and thymalfasin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesChina
Study dates
3 Jan 2024to 1 Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who were fully informed of the study and voluntarily signed the informed consent form;
  • 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.

Who cannot join

  • Patients have a present or previous active malignancy except the diagnosis of rectal cancer this time;
  • Patients underwent major surgery within 4 weeks prior to study treatment;
  • 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 who are allergic to any of the ingredients under study;
  • Patients with severe concomitant diseases with estimated survival ≤ 5 years;
Show all 24Show fewer
  • Patients with present or previous moderate or severe liver and kidney damage presently or previously;
  • Patients have received other study medications or any immunotherapy currently or in the past;
  • Patients preparing for or previously received organ or bone marrow transplant;
  • Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of study therapy;
  • Patients with congenital or acquired immune deficiency (such as HIV infection);
  • 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;
  • 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.
  • Pregnant or lactating women
  • Criteria for Withdrawal:
  • The subject withdraws informed consent;
  • The subject requests to withdraw from the study, or loses follow-up;
  • The subject demonstrates poor compliance and is unable to participate in the treatment and visits as required by the study protocol;
  • The subject experiences intolerable adverse events, and the investigator determines that continuing the study may be detrimental to the subject;
  • Other reasons, where the investigator determines it is not suitable for the subject to continue in the study.
  • Criteria for Study Termination:
  • There are major errors in the study protocol;
  • The study involves significant risks and is terminated following review by the ethics committee;
  • Termination requested by the sponsor or regulatory authorities.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Friendship Hospital,Capital Medical University

    Beijing

  • Peking Union Medical College Hospital

    Beijing

Other trials in China

About this study

Official title: Efficacy and Safety of Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin in pMMR/MSS Locally Advanced Middle and Low Rectal Cancer: An Open, Multi-center, Prospective, Single-arm Phase II Clinical Study

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.

Read the detailed description

This study is an open, prospective, multi-center, single-arm phase II clinical study. In this study, patients with pMMR/MSS locally advanced middle and low rectal cancer were selected as the subjects and treated with neoadjuvant treatment protocol of long-course concurrent chemoradiotherapy combined with PD-1 monoclonal antibody and thymalfasin. The primary endpoint of the study was complete response (CR) rate. The secondary end points included treatment-related adverse events (TRAEs) rate, 30-day incidence of postoperative complications, objective response rate (ORR), 3-year disease-free survival (DFS) rate, Neoadjuvant rectal cancer (NAR) score, R0 resection rate, and anal preservation rate.

Being tested
capecitabine, tislelizumab, thymalfasin, long-term radiotherapy
Keywords
pMMR/MSS, locally Advanced Rectal Cancer, PD-1, neoadjuvant, chemoradiation, Thymalfasin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • capecitabineDrug

    825-1000mg/m2,po,bid

  • tislelizumabDrug

    200mg,iv.gtt,q3w

  • thymalfasinDrug

    4.8mg,sc,biw

  • long-term radiotherapyRadiation

    50 Gy/25 f, 2 Gy/day

Study groups in NCT06056804
Study groupRoleWhat they receive
cCRT+tislelizumab+thymalfasinExperimentalA 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.
Receives: Drug: capecitabine; Drug: tislelizumab; Drug: thymalfasin; Radiation: long-term radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CR rate

    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.

    Measured: from preoperative to 10 days postoperative

Secondary outcomes (7)

  1. TRAE

    incidence of treatment-related adverse event

    Measured: from commencing of treatment to the 30th day after surgery

  2. 30-day incidence of postoperative complications

    incidence of surgical complications within 30 days after surgery

    Measured: within 30 days after surgery

  3. ORR

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

    Measured: before surgery

  4. 3-y DFS rate

    3-year disease free survival rate

    Measured: 3 years

  5. NAR score

    neoadjuvant rectal score

    Measured: within 10 days after surgery

  6. R0 resection rate

    rate of R0 resection

    Measured: within 10 days after surgery

  7. anal preservation rate

    proportion of patients with preserved anal sphincter

    Measured: instantly after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study start3 Jan 2024
  3. Primary completion1 Dec 2024
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
neoadjuvant chemoradiotherapy combined with PD-1 monoclonal antibody and thymalfasin
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06056804
Sponsor's protocol ID
ZDX+PD-1-LARC
Status last verified
Aug 2024
First submitted
21 Sep 2023
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Export of individual patient data is a sensitive issue according to current Chinese laws.

Publications

  • Amin, M. B. et al. AJCC cancer staging manual. (New York: Springer. 252-274 2017)

  • Andre T, Shiu KK, Kim TW, Jensen BV, Jensen LH, Punt C, Smith D, Garcia-Carbonero R, Benavides M, Gibbs P, de la Fouchardiere C, Rivera F, Elez E, Bendell J, Le DT, Yoshino T, Van Cutsem E, Yang P, Farooqui MZH, Marinello P, Diaz LA Jr; KEYNOTE-177 Investigators. Pembrolizumab in Microsatellite-Instability-High Advanced Colorectal Cancer. N Engl J Med. 2020 Dec 3;383(23):2207-2218. doi: 10.1056/NEJMoa2017699.

    PubMed 33264544

  • King RS, Tuthill C. Evaluation of thymosin alpha 1 in nonclinical models of the immune-suppressing indications melanoma and sepsis. Expert Opin Biol Ther. 2015;15 Suppl 1:S41-9. doi: 10.1517/14712598.2015.1008446. Epub 2015 Feb 2.

    PubMed 25643200

  • Danielli R, Cisternino F, Giannarelli D, Calabro L, Camerini R, Savelli V, Bova G, Dragonetti R, Di Giacomo AM, Altomonte M, Maio M. Long-term follow up of metastatic melanoma patients treated with Thymosin alpha-1: investigating immune checkpoints synergy. Expert Opin Biol Ther. 2018 Jul;18(sup1):77-83. doi: 10.1080/14712598.2018.1494717.

    PubMed 30063847

  • Renga G, Bellet MM, Pariano M, Gargaro M, Stincardini C, D'Onofrio F, Mosci P, Brancorsini S, Bartoli A, Goldstein AL, Garaci E, Romani L, Costantini C. Thymosin alpha1 protects from CTLA-4 intestinal immunopathology. Life Sci Alliance. 2020 Aug 14;3(10):e202000662. doi: 10.26508/lsa.202000662. Print 2020 Oct.

    PubMed 32817121

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing capecitabine, tislelizumab and thymalfasin in people with Locally Advanced Rectal Cancer, run by Beijing Friendship Hospital at 2 sites 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 3 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

CR rate (time frame: from preoperative to 10 days postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06056804, which also lists 5 linked publications.

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 2 Apr 2025.

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