Clinical trial · Interventional
PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced SCCA Patients
Neoadjuvant PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced Anal Canal Squamous Carcinoma Patients
NCT05060471CI-TRIAL-00083251completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Canal Cancer | — | UNRESOLVED | — |
| Anal Canal Cancer Stage I | — | UNRESOLVED | — |
| Anal Canal Cancer Stage II | — | UNRESOLVED | — |
| Anal Canal Cancer Stage III | — | UNRESOLVED | — |
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Anal Squamous Cell Carcinoma | Anal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervetional group
- description
- Neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and concurrent toripalimab
- interventionNames
- Drug: Toripalimab
Primary outcomes (1)
- measure
- cCR rate
- timeFrame
- 3 months after treatment
- description
- cCR rate 3 months after treatment
Secondary outcomes (8)
- measure
- cCR rate
- timeFrame
- 6 months after treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: (1) Histology confirmed as anal canal squamous carcinoma; 1. Clinical stage I-III 2. No distant metastasis; 3. Age: 18-75 years old; 4. ECOG 0-1 score 5. Adequate bone marrow, liver, kidney function 6. if HIV infected, HIV loading is below the lower limit (\<20 copy \</ ml), with the number of CD4+T cells \> 300\> ml 7. Non-pregnant or lactating women; 8. 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 9. No other serious disease leading to shortened survival. 10. No previous anal canal surgery or anal tumor resection (except for biopsy); 11. No chemotherapy received within the previous 5 years; 12. No previous pelvic radiation; 13. No biological treatment received in the previous 5 years; 14. No previous immunotherapy received. Exclusion Criteria: 1. Diagnosed as stage I and well differentiated squamous cell carcinoma 2. Distant metastasis 3. Received radiation therapy in abdominal or pelvic regions 4. Pregnant, lactating woman patient or fertile but lacks adequate contraceptives 5. Infectious disease: Active phase chronic hepatitis B or hepatitis C (high copies of virus DNA); Other serious active clinical infection 6. Patients with active tuberculosis (TB) are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening; 7. Chronic inflammatory colorectal disease, unrelieved ileus 8. Dyscrasia or organ decompensation 9. Allergic to research-related drugs 10. Severe hypertension with poor drug control; 11. Epilepsy require medical treatment (such as steroid or antiepileptic therapy); 12. Drug abuse and medical, psychological or social factors that may interfere with patients' participation in the study or affect the evaluation of the study; 13. 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. 14. Received any anti-infection vaccine (e.g. influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment; 15. Complications require long-term treatment with immunosuppressive drugs, or requiring systemic or local use of immunosuppressive corticosteroids(\>10mg/day prednisone or other therapeutic hormones); 16. Any unstable condition or which endangers the patients' safety and compliance; 17. Refuses to sign informed consent
References
Publications (24)
- RESULTSiegel 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. PMID 28055103
- RESULTAmirian 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. PMID 23484057
- RESULTNigro 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. PMID 8348857
- RESULTEpidermoid 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. PMID 8874455
- RESULTNorthover 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. PMID 20354531
- RESULTBartelink 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. PMID 9164216
- RESULTAjani 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.