光免疫治疗在肿瘤领域的临床应用新进展

doi:10.3877/cma.j.issn.1674-0785.2024.06.009

近红外光免疫治疗（NIR-PIT）利用光敏剂耦合单克隆抗体的共轭物与相关性抗原结合，当近红外光照射到肿瘤区域时，共轭物在近红外光照射下发生结构变化通过物理应激方式介导肿瘤细胞或肿瘤相关细胞的损伤和死亡。这种治疗方式具有高度选择性和局部破坏性，可以最大程度地减少对周围正常组织的损伤。鉴于NIR-PIT疗法的高疗效、低毒性的特点，NIR-PIT在多种肿瘤的研究得到快速发展，有望成为一种新型抗肿瘤疗法。目前，多项Ⅰ/Ⅱ期关于NIR-PIT的临床研究结果表明PIT的疗效令人鼓舞，毒性反应可接受。已在头颈部鳞状细胞癌等进行Ⅲ期临床试验评估该治疗模式疗效。本综述文章对NIR-PIT抗肿瘤作用机制、可选的治疗靶点、在各肿瘤的研究进展、NIR的选择与递送，以及面临的挑战等研究进展进行了总结。

关键词: 肿瘤, 光生物调节, 免疫治疗

Near-infrared photoimmunotherapy (NIR-PIT) involves the conjugation of a photosensitizer with a monoclonal antibody that binds to a specific antigen. When near-infrared light is irradiated onto the tumor area, the conjugate undergoes structural changes and induces damage and death of tumor cells or tumor-associated cells through physical stress. This therapy has high selectivity and localized destructive effects, minimizing damage to surrounding normal tissues. Due to its high efficacy and low toxicity, NIR-PIT has rapidly developed as a promising novel anti-tumor therapy in various cancers. Currently, NIR-PIT is undergoing phase Ⅲ clinical trials for the evaluation of its safety and feasibility in the treatment of head and neck squamous cell carcinoma. This review summarizes the anti-tumor mechanisms and potential therapeutic targets of NIR-PIT, its research progress in various tumors, and the selection and delivery of NIR, as well as the challenges faced by this therapy.

Key words: Tumor, Photobiomodulation, Immunotherapy

表1 不同肿瘤的潜在分子靶向抗原

肿瘤种类	靶向分子抗体	肿瘤种类	靶向分子抗体
头颈部肿瘤	EGFR^[19]，CD44^[20]，CD25^[21]，CTLA4^[22]	食管癌	EGFR^[23]，HER2^[24]，FAP^[23,24,25]
乳腺癌	EGFR^[26-27]，CD44^[28]，HER2^[29-30]，ICAM1^[31]，FAP^[32]	胃癌	HER2^[33]，CD44^[34]，CEA^[35]
肺癌	EGFR^[36]，HER2^[37-38]，PD-L1^[39]，DLL3^[40]，MRP1^[41-42]，CD25^[21]，CD206^[43]，CTLA4^[44]，GPR87^[45]	结直肠癌	CEA^[46]，GPA33^[47]
胶质瘤	EGFR^[48-49]，CD133^[50]	黑色素瘤	CD29^[51]，D146^[52]
泌尿生殖肿瘤	EGFR^[53]，HER2^[54]，CD47^[55]，PD-L1^[56]，GSA^[57]，PSMA^[58]，GPC-1^[59]，CD44^[60]

表1 不同肿瘤的潜在分子靶向抗原

肿瘤种类	靶向分子抗体	肿瘤种类	靶向分子抗体
头颈部肿瘤	EGFR^[19]，CD44^[20]，CD25^[21]，CTLA4^[22]	食管癌	EGFR^[23]，HER2^[24]，FAP^[23,24,25]
乳腺癌	EGFR^[26-27]，CD44^[28]，HER2^[29-30]，ICAM1^[31]，FAP^[32]	胃癌	HER2^[33]，CD44^[34]，CEA^[35]
肺癌	EGFR^[36]，HER2^[37-38]，PD-L1^[39]，DLL3^[40]，MRP1^[41-42]，CD25^[21]，CD206^[43]，CTLA4^[44]，GPR87^[45]	结直肠癌	CEA^[46]，GPA33^[47]
胶质瘤	EGFR^[48-49]，CD133^[50]	黑色素瘤	CD29^[51]，D146^[52]
泌尿生殖肿瘤	EGFR^[53]，HER2^[54]，CD47^[55]，PD-L1^[56]，GSA^[57]，PSMA^[58]，GPC-1^[59]，CD44^[60]

表2 目前正在开展的PIT相关临床试验^*

CT的ID号	主要病种	CT期别	主要入组标准	拟入组例数	终点指标	状态	预计完成时间
NCT00758797	皮肤转移性黑色素瘤	1期	皮肤转移性恶性黑色素瘤、需有可测量病灶、PS评分0~2	7	主要指标：PIT耐受性和安全性；次要指标：PFS、OS、DOR	终止	2012.10研究终止
NCT05220748	HNSCC	1期	HNSCC或皮肤鳞癌、一线含铂化疗后R/M且不适合行局部治疗、至少有一个皮肤或口腔浅表病变可行PIT、PS评分0~2	36	主要指标：Ia期：PIT疗法安全性及可行性；Ib期：PIT联合帕博利珠治疗安全性及可行性；次要指标：药物血液浓度及有效率	撤销	2023.01.30因无法招募患者入组而撤销研究
NCT03769506	HNSCC	3期	无法根治的R-HNSCC、至少2线治疗后且为含铂类药物治疗失败或进展、接受过头颈部治疗性放射治疗、所有病灶均可进行PIT照射、有可评价病灶	275	主要指标：总生存期、无疾病进展生存期；次要指标：客观缓解率	招募中	2024.12.30
NCT02422979	HNSCC	1期/2期	不适合手术或放疗、接受含铂方案化疗的R-HNSCC、PS评分0~2	实际入组40	主要指标：1期：RM-1929的MTD或MFD、药物剂量与PIT的安全性；2期：1、固定剂量与固定轻剂量的最大耐受剂量(MTD)或最大可行剂量(MFD)；2、重复给药的安全性	完成	2019.02.25
NCT05182866	R/M或皮肤鳞癌	2期单臂	R/M或皮肤鳞癌、至少有一个病灶可用于ASP-1929 治疗和评价、PS评分0或1	22	主要指标：pCR；次要指标：1年的局部复发率、DFS、PFS、2年OS	招募中	2025.09.18
NCT04305795	R/M HNSCC或R/M皮肤鳞癌	1期2期	不适合行放疗或手术的R/M HNSCC或皮肤鳞癌、PS评分0或1、至少一个可治疗和评价病灶	74	主要指标：PIT联合ICIs的毒性与安全性、ORR、DOR；次要指标：2年OS、PFS	准备招募	2025.06
NCT05265013	R/M HNSCC	2期单臂	含铂方案治疗后进展、不适合行放疗或手术局部治疗的R/M HNSCC、CPS评分>1、未接受ICIs治疗、已接受过头颈部放疗、PS评分0或1分	33	主要指标：ORR；次要指标：DOR、2年OS、PFS	准备招募	2024.04

表2 目前正在开展的PIT相关临床试验^*

CT的ID号	主要病种	CT期别	主要入组标准	拟入组例数	终点指标	状态	预计完成时间
NCT00758797	皮肤转移性黑色素瘤	1期	皮肤转移性恶性黑色素瘤、需有可测量病灶、PS评分0~2	7	主要指标：PIT耐受性和安全性；次要指标：PFS、OS、DOR	终止	2012.10研究终止
NCT05220748	HNSCC	1期	HNSCC或皮肤鳞癌、一线含铂化疗后R/M且不适合行局部治疗、至少有一个皮肤或口腔浅表病变可行PIT、PS评分0~2	36	主要指标：Ia期：PIT疗法安全性及可行性；Ib期：PIT联合帕博利珠治疗安全性及可行性；次要指标：药物血液浓度及有效率	撤销	2023.01.30因无法招募患者入组而撤销研究
NCT03769506	HNSCC	3期	无法根治的R-HNSCC、至少2线治疗后且为含铂类药物治疗失败或进展、接受过头颈部治疗性放射治疗、所有病灶均可进行PIT照射、有可评价病灶	275	主要指标：总生存期、无疾病进展生存期；次要指标：客观缓解率	招募中	2024.12.30
NCT02422979	HNSCC	1期/2期	不适合手术或放疗、接受含铂方案化疗的R-HNSCC、PS评分0~2	实际入组40	主要指标：1期：RM-1929的MTD或MFD、药物剂量与PIT的安全性；2期：1、固定剂量与固定轻剂量的最大耐受剂量(MTD)或最大可行剂量(MFD)；2、重复给药的安全性	完成	2019.02.25
NCT05182866	R/M或皮肤鳞癌	2期单臂	R/M或皮肤鳞癌、至少有一个病灶可用于ASP-1929 治疗和评价、PS评分0或1	22	主要指标：pCR；次要指标：1年的局部复发率、DFS、PFS、2年OS	招募中	2025.09.18
NCT04305795	R/M HNSCC或R/M皮肤鳞癌	1期2期	不适合行放疗或手术的R/M HNSCC或皮肤鳞癌、PS评分0或1、至少一个可治疗和评价病灶	74	主要指标：PIT联合ICIs的毒性与安全性、ORR、DOR；次要指标：2年OS、PFS	准备招募	2025.06
NCT05265013	R/M HNSCC	2期单臂	含铂方案治疗后进展、不适合行放疗或手术局部治疗的R/M HNSCC、CPS评分>1、未接受ICIs治疗、已接受过头颈部放疗、PS评分0或1分	33	主要指标：ORR；次要指标：DOR、2年OS、PFS	准备招募	2024.04

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Recent advances in application of near-infrared photoimmunotherapy in cancer

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Recent advances in application of near-infrared photoimmunotherapy in cancer