Chemoradiotherapy Combined With or Without PD-1 Blockade in Anal Canal Squamous Carcinoma Patients
NCT ID: NCT05374252
Last Updated: 2022-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
102 participants
INTERVENTIONAL
2022-05-07
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pd1 Antibody Sintilimab ± Chemoradiotherapy for Locally Advanced Rectal Cancer
NCT04304209
Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal Patients With Locally Advanced Rectal CancerPatients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study
NCT05998122
Radical Concurrent Chemoradiotherapy With DDP/5-FU and PD-1 Antibody for Non-metastatic Rectal Squamous Cell Carcinoma
NCT06364384
Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer
NCT03381352
Radiotherapy in Combination With Sintilimab，GM-CSF and Fruquintinib in Patients With MSS mCRC
NCT05292417
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental Group
Concurrent PD-1 antibody sintilimab combined with mytomicin C, 5-fluorouracil, and IMRT, followed by adjuvant sintilimab
PD-1 inhibitor
Two cycles of concurrent PD-1 antibody sintilimab combined with mytomicin C, 5-fluorouracil and IMRT, followed by adjuvant sintilimab for six months
Control Group
Concurrent mytomicin C and 5-fluorouracil combined with IMRT
concurrent chemoradiotherapy
Two cycles of concurrent mytomicin C and 5-fluorouracil combined with IMRT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PD-1 inhibitor
Two cycles of concurrent PD-1 antibody sintilimab combined with mytomicin C, 5-fluorouracil and IMRT, followed by adjuvant sintilimab for six months
concurrent chemoradiotherapy
Two cycles of concurrent mytomicin C and 5-fluorouracil combined with IMRT
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Aged 18 to 75,
3. Clinical staging III, Eastern Cooperative Oncology Group 0-2 score,
4. The Staging method: All patients undergoing rectal anus palpation, high resolution MRI and chest-abdominal enhanced CT, clinical data should be re-evaluated and inclusive by center evaluation group when there is contradictory staging, distant metastasis were excluded by chest-abdominal enhanced CT and pelvic enhanced MRI,
5. No previous anal canal surgery or anal tumor resection (except for biopsy),
6. No previous chemotherapy or pelvic radiotherapy history,
7. No biopharmaceutical treatment history (such as monoclonal antibody), immunotherapy (such as anti PD-1antibody, anti PD-L1 antibody, anti PD-L2 antibody or anti CTLA-4), or other research drug treatment in the previous 5 years,
8. Adequate bone marrow, liver, and kidney function,
9. Clinical complete response (cCR) (Chest, abdominal and pelvic enhanced CT or pelvic enhanced MRI or PET/CT),
11. Non-pregnant or breast-feeding women,
12. 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,
13. No other serious disease leading to shortened survival.
Exclusion Criteria
2. Distant metastasis,
3. Received radiation therapy in abdominal or pelvic regions,
4. Pregnant, lactating woman patient or fertile but lacks adequate contraceptives,
5. Arrhythmia need anti-arrhythmia treatment (except β-blocking agent or Digoxin), symptomatic coronary heart disease or myocardial ischemia (myocardial infarction within 6 months) or congestive heart-failure (CHF) \> New York Heart Association grade II,
6. Severe hypertension not well controlled by drugs,
7. Active phase of chronic hepatitis B or hepatitis C (high copies of virus DNA),
8. Patients with active tuberculosis (TB) are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening,
9. Other active clinical severe infection (NCI-CTCAE (version 4.0) ),
10. Dyscrasia, organ dysfunction,
11. Known or suspicious allergy to any research-related drugs,
12. Epilepsy needs treatments (Steroid or anti-epilepsy therapy),
13. Other malignant tumor history within 5 years,
14. Drug abuse and medical, psychological, or social factors that may interfere with patients' participation in the study or affect the evaluation of the study,
15. Patients have any active autoimmune diseases or a history of autoimmune diseases (including but not restricted: 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,
16. Any anti-infection vaccine 4 weeks before inclusion,
17. Long-term exposure to immune-suppressor, combination of systemic or topical use of corticosteroids (dose\>10mg/day prednisolone or equivalent hormone),
18. Any unstable state might endanger the patients' safety and compliance,
19. Refuses to sign informed consent.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xiang-bo Wan, PhD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Gunderson LL, Moughan J, Ajani JA, Pedersen JE, Winter KA, Benson AB 3rd, Thomas CR Jr, Mayer RJ, Haddock MG, Rich TA, Willett CG. Anal carcinoma: impact of TN category of disease on survival, disease relapse, and colostomy failure in US Gastrointestinal Intergroup RTOG 98-11 phase 3 trial. Int J Radiat Oncol Biol Phys. 2013 Nov 15;87(4):638-45. doi: 10.1016/j.ijrobp.2013.07.035. Epub 2013 Sep 10.
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.
Ben-Josef E, Moughan J, Ajani JA, Flam M, Gunderson L, Pollock J, Myerson R, Anne R, Rosenthal SA, Willett C. Impact of overall treatment time on survival and local control in patients with anal cancer: a pooled data analysis of Radiation Therapy Oncology Group trials 87-04 and 98-11. J Clin Oncol. 2010 Dec 1;28(34):5061-6. doi: 10.1200/JCO.2010.29.1351. Epub 2010 Oct 18.
Ott PA, Piha-Paul SA, Munster P, Pishvaian MJ, van Brummelen EMJ, Cohen RB, Gomez-Roca C, Ejadi S, Stein M, Chan E, Simonelli M, Morosky A, Saraf S, Emancipator K, Koshiji M, Bennouna J. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal. Ann Oncol. 2017 May 1;28(5):1036-1041. doi: 10.1093/annonc/mdx029.
Shahjehan F, Kamatham S, Ritter A, Kasi PM. Dramatic response to modified docetaxel, cisplatin, and fluorouracil chemotherapy after immunotherapy in a patient with refractory metastatic anal cancer. Clin Case Rep. 2019 Aug 6;7(9):1729-1734. doi: 10.1002/ccr3.2333. eCollection 2019 Sep.
Nigro ND, Vaitkevicius VK, Considine B Jr. Combined therapy for cancer of the anal canal: a preliminary report. Dis Colon Rectum. 1974 May-Jun;17(3):354-6. doi: 10.1007/BF02586980. No abstract available.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
E2021144
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.