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. 2022 Mar 17;13:795972. doi: 10.3389/fimmu.2022.795972

Table 2.

Ongoing clinical trials of nIT for LACRC.

NCT number Study Title Phase of trial Number of participants Condition Intervention Primary outcome measures Secondary outcome measures Trial status
NCT04130854 INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer, a Phase II Randomized Multi-center Trial of Neoadjuvant Therapy With and Without APX005M, an Anti-CD40 Agonist, APX005M, for Locally Advanced Rectal Adenocarcinoma II 58 LARC Experimental: APX005M(an anti-CD40 agonist)on day 3 of SCRT(5Gy x 5 days) and on day 3 of cycles 1-5 of mFOLFOX → the 6th cycle of only mFOLFOX → Surgery; Active Comparator: SCRT(5Gy x 5 days) + 6 cycle of mFOLFOX →Surgery pCR rate

  1. OS

  2. DFS

  3. Rate of resection

  4. Safety and tolerability

  5. Disease recurrence

  6. Development of disease

  7. Clinical imaging response

  8. cCR rate

 Recruiting
NCT04165772 A Phase II Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Rectal Adenocarcinoma II 30 MSI-H/dMMR LARC 9 cycles of TSR-042 (a PD-1 antibody, 500mg; q3w); participants who exhibit CR will proceed to W&W; participants who do not have a CR will received standard nCRT →Surgery pCR rate; cCR rate / Recruiting
NCT04304209 PD-1 Antibody Sintilimab ± Chemoradiotherapy for Locally Advanced Rectal Cancer II/III 25 LARC (cohort A:dMMR/MSI-H; Cohort B:pMMR/MSS MSI-L;) Cohort A: 4 cycles of Sintilimab(a PD-1 antibody) → Surgery or W&W → 4 cycles of Sintilimab ± CapeOx according to pathologic response; Cohort B-arm 1: 4 cycles of Sintilimab, nCRT with CapeOx → Surgery or W&W, → 4 cycles of Cape0x; Cohort B-arm 2: 4 cycles of nCRT with CapeOx → Surgery or W&W → 4 cycles of CapeOx pCR rate

  1. Acute toxicities

  2. TRG

  3. R0 resection rate

  4. Surgical complication

  5. Local recurrence

  6. Distant metastasis

  7. 3-year DFS

 Recruiting
NCT03985891 A Randomized, Prospective Clinical Trial of Safety and Efficacy of JS001 Combined With Chemotherapy in Patients With Locally Advanced Colon Cancer (Perioperative Treatment) I/II 40 LACC Experimental: JS001(a PD-1 antibody) in combination with FOLFOX for 6 cycles before and after operation. Active Comparator: FOLFOX for 6 cycles before and after operation. pCR rate; cCR rate; ORR

  1. DFS

  2. OS

 Recruiting
NCT03299660 Phase II Trial PD-L1/PD-1 Blockade Avelumab (MSB0010718C) With Chemoradiotherapy for Locally Advanced Resectable Rectal Cancer II 45 LARC nCRT with capecitabine for 6 weeks → 4 cycles of Avelumab(a PD-L1 antibody) → Surgery pCR rate

  1. Response as per structural imaging

  2. Overall FDG PET response

  3. Toxicity

  4. Rate of downstaging

 Recruiting
NCT04340401 A Phase II Study of Total Neoadjuvant Therapy Plus SHR1210 for High-risk Locally Advanced Rectal Cancer and Biomarker Screening Base on Neoantigen II 25 LARC 3 cycles Capeox+SHR-1210(an anti-PD-1 inhibitor) → nCRT with capecitabine → 2 cycles CapeOx → Surgery pCR rate

  1. Toxicity of TNT+SHR-1210

  2. Change of TCR repertoire

  3. DFS

  4. Surgical complication rate

  5. Major AEs

 Recruiting
NCT04230759 Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma. A Multicenter, Randomized, Phase II Trial of the German Anal Cancer Study Group (RADIANCE) II 178 LASCC Experimental: 5FU+Mitomycin C-based radiochemotherapy+Durvalumab (a PD-L1 antibody); Active Comparator: 5FU+Mitomycin C -based Radiochemotherapy DFS

  1. Major AEs

  2. cCR

  3. OS

  4. Colostomy-free survival

  5. locoregional recurrence

  6. Distant recurrence

  7. Quality of life

  8. questionnaires

 Recruiting
NCT04293419 Phase II Study of Durvalumab (MEDI4736) Plus Total Neoadjuvant Therapy (TNT) in Locally Advanced Rectal Cancer (The DUREC Trial) II 58 LARC 6 cycles of mFOLFOX6 → nCRT with capecitabine → Surgery. Patients will receive durvalumab(a PD-L1 antibody,1500mg;q4w) during induction chemotherapy, nCRT and waiting period until surgery pCR rate

  1. Tumor downstaging

  2. TRG

  3. R0 resection rate

  4. 3-year DFS

  5. Toxicity profile

  6. Surgical complications

  7. NAR score

 Recruiting
NCT03127007 A Phase Ib/II Study to Evaluate Safety and Efficacy of Atezolizumab Combined With Radio-chemotherapy in a Preoperative Setting for Patients With Localized Rectal Cancer (R-IMMUNE) I/II 54 LARC Experimental: nCRT with 5-FU, Atezolizumab (a PD-L1 antibody, 1200mg) is given on day 1 of week 3, 6, 9 and 12. Surgery is planned during week 15; Active Comparator: nCRT with 5-FU. Surgery is planned during week 15 Rate of AEs; pCR rate / Recruiting
NCT05202314 Camrelizumab Combined With Neoadjuvant Chemotherapy After Stent Placement for Left-Sided Obstructive Colonic Cancer (NACSOC-02) II 20 Obstructive colonic cancer Camrelizumab (a PD-1 antibody, 200mg) 2 cycles + mFOLFOX6 3 cycles or CapeOx 2 cycles → Surgery pCR rate

  1. 3-year OS

  2. 3-year DFS

 Recruiting

LARC, Locally advanced rectal cancer; LACC, Locally advanced colon cancer; LASCC, locally-advanced anal squamous cell carcinoma; nIT, Neoadjuvant immunotherapy; nCRT, Neoadjuvant chemoradiotherapy; SCRT, Short-Course Radiotherapy; TNT, Total Neoadjuvant Therapy; dMMR, Deficient mismatch repair; pMMR, Proficient mismatch repair; MSI-H, Microsatellite instability-high; MSI-L, Microsatellite instability-low; MSS, Microsatellite stability; ORR,Objective response rate; TRG, Tumor regression grade; CR, Complete response; pCR, Pathological complete response; cCR, Clinical complete response; W&W, Watch & wait; NAR, Neoadjuvant rectal score; AEs, Adverse effects; OS, Overall survival; DFS, Disease free survival; TCR, T Cell Receptor.