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Anal Canal CancerPhase 2NCT05060471

PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced SCCA Patients

A Phase 2 study testing Toripalimab in people with Anal Canal Cancer and Anal Squamous Cell Carcinoma, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Locally Advanced Anal Canal Squamous Carcinoma Patients will be enrolled and given four cycles of neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and two cycles of concurrent toripalimab. Treatment outcomes and toxicities will be evaluated. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
27 Oct 2021to 27 Nov 2024
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histology confirmed as anal canal squamous carcinoma;
  • Clinical stage I-III
  • No distant metastasis;
  • Age: 18-75 years old;
  • ECOG 0-1 score
  • Adequate bone marrow, liver, kidney function
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  • if HIV infected, HIV loading is below the lower limit (<20 copy </ ml), with the number of CD4+T cells > 300> ml
  • Non-pregnant or lactating women;
  • No other malignant disease within 5 years before diagnosis of anal cancer squamous carcinoma (except endocervical cancer in situ or skin basal cell carcinoma which had been cured); no other malignant disease beside anal cancer squamous carcinoma
  • No other serious disease leading to shortened survival.
  • No previous anal canal surgery or anal tumor resection (except for biopsy);
  • No chemotherapy received within the previous 5 years;
  • No previous pelvic radiation;
  • No biological treatment received in the previous 5 years;
  • No previous immunotherapy received.

Who cannot join

  • Diagnosed as stage I and well differentiated squamous cell carcinoma
  • Distant metastasis
  • Received radiation therapy in abdominal or pelvic regions
  • Pregnant, lactating woman patient or fertile but lacks adequate contraceptives
  • Infectious disease: Active phase chronic hepatitis B or hepatitis C (high copies of virus DNA); Other serious active clinical infection
  • Patients with active tuberculosis (TB) are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening;
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  • Chronic inflammatory colorectal disease, unrelieved ileus
  • Dyscrasia or organ decompensation
  • Allergic to research-related drugs
  • Severe hypertension with poor drug control;
  • Epilepsy require medical treatment (such as steroid or antiepileptic therapy);
  • Drug abuse and medical, psychological or social factors that may interfere with patients' participation in the study or affect the evaluation of the study;
  • Patients have any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism and decreased thyroid function; patients with vitiligo or with complete remission of asthma in childhood and without any intervention in adulthood may be included; patients with asthma requiring bronchodilators intervention are not included.
  • Received any anti-infection vaccine (e.g. influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment;
  • Complications require long-term treatment with immunosuppressive drugs, or requiring systemic or local use of immunosuppressive corticosteroids(>10mg/day prednisone or other therapeutic hormones);
  • Any unstable condition or which endangers the patients' safety and compliance;
  • Refuses to sign informed consent

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Neoadjuvant PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced Anal Canal Squamous Carcinoma Patients

Locally Advanced Anal Canal Squamous Carcinoma Patients will be enrolled and given four cycles of neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and two cycles of concurrent toripalimab. Treatment outcomes and toxicities will be evaluated.

Being tested
Toripalimab
Medical subject headings
Anal Canal Carcinoma, Anus Neoplasms

What participants receive

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

  • ToripalimabDrug

    Also called radiation

    Four cycles of neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and two cycles of concurrent toripalimab.

Study groups in NCT05060471
Study groupRoleWhat they receive
Intervetional groupExperimentalNeoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and concurrent toripalimab
Receives: Drug: Toripalimab

What is being measured

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

  1. cCR rate

    cCR rate 3 months after treatment

    Measured: 3 months after treatment

Secondary outcomes (8)

  1. cCR rate

    cCR rate 6 months after treatment

    Measured: 6 months after treatment

  2. acute toxicities

    acute toxicities

    Measured: from the start of treatment to 3 months after treatment

  3. late toxicities

    late toxicities

    Measured: 3 months after treatment

  4. colostomy rate

    colostomy rate

    Measured: from the end of treatment to 2 years after treatment

  5. local recurrence rate

    local recurrence rate

    Measured: from the end of treatment to 5 years after treatment

  6. distant metastasis rate

    distant metastasis rate

    Measured: from the end of treatment to 5 years after treatment

  7. progression free survival

    progression free survival

    Measured: from the end of treatment to 5 years after treatment

  8. overall sruvival

    overall sruvival

    Measured: from the end of treatment to 5 years after treatment

Timeline

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

  1. First posted29 Sep 2021
  2. Study start27 Oct 2021
  3. Primary completion21 Jun 2024
  4. Study completion27 Nov 2024

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
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05060471
Sponsor's protocol ID
B2021-137-01
Status last verified
Nov 2024
First submitted
19 Sep 2021
Last updated
3 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study data can be shared after publication of the study results, upon request.

Publications

  • Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.

    PubMed 28055103

  • Amirian ES, Fickey PA Jr, Scheurer ME, Chiao EY. Anal cancer incidence and survival: comparing the greater San-Francisco bay area to other SEER cancer registries. PLoS One. 2013;8(3):e58919. doi: 10.1371/journal.pone.0058919. Epub 2013 Mar 6.

    PubMed 23484057

  • Nigro ND, Vaitkevicius VK, Considine B Jr. Combined therapy for cancer of the anal canal: a preliminary report. 1974. Dis Colon Rectum. 1993 Jul;36(7):709-11. doi: 10.1007/BF02238600. No abstract available.

    PubMed 8348857

  • Epidermoid anal cancer: results from the UKCCCR randomised trial of radiotherapy alone versus radiotherapy, 5-fluorouracil, and mitomycin. UKCCCR Anal Cancer Trial Working Party. UK Co-ordinating Committee on Cancer Research. Lancet. 1996 Oct 19;348(9034):1049-54.

    PubMed 8874455

  • Northover J, Glynne-Jones R, Sebag-Montefiore D, James R, Meadows H, Wan S, Jitlal M, Ledermann J. Chemoradiation for the treatment of epidermoid anal cancer: 13-year follow-up of the first randomised UKCCCR Anal Cancer Trial (ACT I). Br J Cancer. 2010 Mar 30;102(7):1123-8. doi: 10.1038/sj.bjc.6605605. Epub 2010 Mar 16.

    PubMed 20354531

  • Bartelink H, Roelofsen F, Eschwege F, Rougier P, Bosset JF, Gonzalez DG, Peiffert D, van Glabbeke M, Pierart M. Concomitant radiotherapy and chemotherapy is superior to radiotherapy alone in the treatment of locally advanced anal cancer: results of a phase III randomized trial of the European Organization for Research and Treatment of Cancer Radiotherapy and Gastrointestinal Cooperative Groups. J Clin Oncol. 1997 May;15(5):2040-9. doi: 10.1200/JCO.1997.15.5.2040.

    PubMed 9164216

  • Ajani JA, Winter KA, Gunderson LL, Pedersen J, Benson AB 3rd, Thomas CR Jr, Mayer RJ, Haddock MG, Rich TA, Willett C. Fluorouracil, mitomycin, and radiotherapy vs fluorouracil, cisplatin, and radiotherapy for carcinoma of the anal canal: a randomized controlled trial. JAMA. 2008 Apr 23;299(16):1914-21. doi: 10.1001/jama.299.16.1914.

    PubMed 18430910

  • Sana S, Khan AU. Clinical trials in the management of anal cancer. Clin Colon Rectal Surg. 2009 May;22(2):115-9. doi: 10.1055/s-0029-1223843.

    PubMed 20436836

  • Chakravarthy AB, Catalano PJ, Martenson JA, Mondschein JK, Wagner H, Mansour EG, Talamonti MS, Benson AB. Long-term follow-up of a Phase II trial of high-dose radiation with concurrent 5-fluorouracil and cisplatin in patients with anal cancer (ECOG E4292). Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e607-13. doi: 10.1016/j.ijrobp.2011.02.042. Epub 2011 Apr 20.

    PubMed 21514072

  • James RD, Glynne-Jones R, Meadows HM, Cunningham D, Myint AS, Saunders MP, Maughan T, McDonald A, Essapen S, Leslie M, Falk S, Wilson C, Gollins S, Begum R, Ledermann J, Kadalayil L, Sebag-Montefiore D. Mitomycin or cisplatin chemoradiation with or without maintenance chemotherapy for treatment of squamous-cell carcinoma of the anus (ACT II): a randomised, phase 3, open-label, 2 x 2 factorial trial. Lancet Oncol. 2013 May;14(6):516-24. doi: 10.1016/S1470-2045(13)70086-X. Epub 2013 Apr 9.

    PubMed 23578724

  • Olsen JR, Moughan J, Myerson R, Abitbol A, Doncals DE, Johnson D, Schefter TE, Chen Y, Fisher B, Michalski J, Narayan S, Chang A, Crane CH, Kachnic L. Predictors of Radiation Therapy-Related Gastrointestinal Toxicity From Anal Cancer Dose-Painted Intensity Modulated Radiation Therapy: Secondary Analysis of NRG Oncology RTOG 0529. Int J Radiat Oncol Biol Phys. 2017 Jun 1;98(2):400-408. doi: 10.1016/j.ijrobp.2017.02.005. Epub 2017 Feb 13.

    PubMed 28463160

  • Pan YB, Maeda Y, Wilson A, Glynne-Jones R, Vaizey CJ. Late gastrointestinal toxicity after radiotherapy for anal cancer: a systematic literature review. Acta Oncol. 2018 Nov;57(11):1427-1437. doi: 10.1080/0284186X.2018.1503713. Epub 2018 Sep 28.

    PubMed 30264638

  • Hosni A, Han K, Le LW, Ringash J, Brierley J, Wong R, Dinniwell R, Brade A, Dawson LA, Cummings BJ, Krzyzanowska MK, Chen EX, Hedley D, Knox J, Easson AM, Lindsay P, Craig T, Kim J. The ongoing challenge of large anal cancers: prospective long term outcomes of intensity-modulated radiation therapy with concurrent chemotherapy. Oncotarget. 2018 Apr 17;9(29):20439-20450. doi: 10.18632/oncotarget.24926. eCollection 2018 Apr 17.

    PubMed 29755663

  • Russo S, Anker CJ, Abdel-Wahab M, Azad N, Bianchi N, Das P, Dragovic J, Goodman KA, Jones W 3rd, Kennedy T, Kumar R, Lee P, Sharma N, Small W, Suh WW, Jabbour SK. Executive Summary of the American Radium Society Appropriate Use Criteria for Treatment of Anal Cancer. Int J Radiat Oncol Biol Phys. 2019 Nov 1;105(3):591-605. doi: 10.1016/j.ijrobp.2019.06.2544. Epub 2019 Jul 6. No abstract available.

    PubMed 31288054

  • Stewart DB, Gaertner WB, Glasgow SC, Herzig DO, Feingold D, Steele SR; Prepared on Behalf of the Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for Anal Squamous Cell Cancers (Revised 2018). Dis Colon Rectum. 2018 Jul;61(7):755-774. doi: 10.1097/DCR.0000000000001114. No abstract available.

    PubMed 29878949

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab in people with Anal Canal Cancer and Anal Squamous Cell Carcinoma, run by Sun Yat-sen University 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 15 inclusion and 17 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 3 Dec 2024. 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.

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?

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?

cCR rate (time frame: 3 months after treatment). 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 NCT05060471, which also lists 24 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 3 Dec 2024.

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